Manufacturing Experience Research Articles

An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for MAGnetic Expansion Control Spinal Rods

Abstract Background MAGnetic Expansion Control (MAGEC) rods can prevent repeated lengthening operations for scoliosis patients. However, there have been several Field Safety Notices issued, including a worldwide product recall due to actuator endcap separation. We aimed to review adverse events reported to the Food and Drug Administration (FDA) regarding MAGEC rods, focusing on MAGEC X. Methods Reports submitted to the Manufacturer and User Facility Device Experience database in relation to MAGEC devices were accessed and analysed using R Statistical Software. Exclusion criteria included duplicate and literature review reports (n = 54). Free-text data were analysed using inductive content analysis. Results 1016 adverse events were reported to 11/30/2023. 99.0% (1006) were submitted by the manufacturer. Reports primarily arose from the UK (465, 45.8%) or US (421, 41.4%). From free-text data the most frequent adverse events were distraction mechanism failure (573), device wear (272), and actuator seal damage (180). Rod fracture (n = 48) was not significantly associated with rod diameter (≤ 5.0 mm or > 5.0 mm), p = 0.736. 234 reports referenced MAGEC X devices; actuator endcap separation was identified in 41.9% (99). Other events include failure of distraction (63), surface damage (31), and rod fracture (15). On 06/30/2020 MAGEC X2 received FDA approval. Twenty reports reference devices manufactured after this date, seven describe distraction mechanism failure; notably there are no reports of endcap separation. Conclusion These data represent the largest series of adverse events reported for MAGEC rods, including significant new data regarding MAGEC X. As well as endcap separation, failure of distraction, surface damage, and rod fracture were reported.

Abstract 4146315: Complications Associated With the 4798 Attain Stability Active Fixation Coronary Sinus Lead: Insights from the MAUDE Registry

Background: The Attain Stability Quad 4798 [Medtronic, Minneapolis, MN] lead was recently developed with a mechanism for active fixation into the venous wall, allowing for precise and secure placement in coronary venous branches. However, real-world data regarding complication rates are limited. Research Question: What are the real-world complications of the Medtronic 4798 lead? Goals: We reviewed the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for adverse events associated with the 4798 lead. Methods: We reviewed the MAUDE database on November 15, 2023, for all reported complications due to the 4798 lead from January 1, 2018 – a year before the lead was approved by the FDA – to the present. Results: A total of 2011 reports of adverse events occurred in mostly males (67.9%) patients with an average age of 70.86±12.1 years. Leads were used most frequently in 2023 (32.3%) for initial use (65.5%) but events commonly occurred intra-procedurally (73.7%). Device malfunction occurred in 43.4% of cases and included but was not limited to adverse events without an identified device problem (33.9%), device dislodgment (24.1%), infection (21.1%), and failure to capture (18.4%). In several cases, the guidewire was stuck (10.7%), or lead dislodgement (27.9%) occurred, resulting in direct helix damage (10.1%). Malfunctions resulted in injury and death in 55.8% and 1.1% of cases, respectively. Conclusions: The use of an active fixation CS lead has been associated with a significant incidence of intraprocedural helix mechanism malfunction. Further real-world surveillance and registry data can help clarify the true incidence of lead failure.

Abstract 4136286: Safety Events with a Large-Bore Aspiration Thrombectomy Device for Pulmonary Embolism: An analysis of the U.S. Food and Drug Administration Manufacturer and User Facility Device Experiences from 2018 to 2024

Introduction: Large bore thrombectomy is increasingly used to treat acute PE. Post-market surveillance using the U.S. FDA Manufacturer and User Facility Device Experience (MAUDE) database may capture serious device adverse events (AE) not described in small pre-market clinical trials. We aim to analyze serious AE associated with use of the Inari Medical (Irvine, California) large bore thrombectomy system to treat PE. Methods: All MAUDE events between January 1, 2018 and May 1, 2024 involving PE treatment with Triever and Flowtriever devices were reviewed and categorized based on device type, incident year, and clinical event. Based on narrative description, AE were placed into categories of cardiac, pulmonary, device malfunction, anemia, and other. Results: A total of 58 AE reports representing 50 unique clinical episodes were included. MAUDE event types were death (n=32), injury (n=23) and malfunction (n=3), and the majority (45/58) involved the larger aspiration catheters (Table 1). Death occurred in 27 of 50 unique episodes. Cardiac injury (n=19) and pulmonary injury (n=18) were most common and included 25 serious perforations. Serious AEs are listed in Table 2. Device malfunction/improper use was rare (n=7) and was not associated with death. Paradoxical embolism was described causing stroke and coronary occlusion. 3 of 4 blood loss AEs occurred prior to 2021. Conclusion: This report includes the largest description of reported AEs with large bore aspiration thrombectomy systems used to treat PE. This report describes serious events, often associated with death, that are likely infrequent and were not detected in pivotal studies or registries. Understanding these AEs may guide future technique and device refinement, and the current findings demonstrate the importance of large post-approval studies.

An Analysis of the Complication Reports of Expandable Lumbar Interbody Cages in the Food and Drug Administration Manufacturer and User Facility Device Experience Database.

Expandable lumbar interbody cages (ELICs) are commonly used for interbody fusion and provide lordotic correction by lengthening the anterior column of the vertebral spine. We sought to identify unique failure mechanisms and significant differences in the types of complications associated with ELICs as reported to the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) Database. The MAUDE Database was analyzed for complication reports submitted for ELIC systems between January 2013 and July 2023. Reports were categorized by manufacturer, brand name, type of expandable cage, type of complication, year of complication, and reporter identity. Reports that were duplicated or had insufficient information were excluded from analysis. The top 5 manufacturers with the most implant-related complications were independently analyzed and compared. A total of 821 reports were analyzed. The top 5 complications reported across all manufacturers were cage breakage during insertion (25.7%), postoperative migration without collapse (16.0%), postoperative collapse (15.6%), inserter breakage (11.1%), and tubing problems (3.0%). A significant difference was detected in complication type between manufacturers (χ2=557, P<.001). The largest number of reports (120, 14.6%) was in 2016. With FDA approval of novel ELIC systems and the adoption of newer surgical techniques, understanding the range of potential complications is paramount in ensuring patient safety. This study of the MAUDE Database provides a comprehensive summary of adverse reported events associated with ELICs during the past decade. [Orthopedics. 202x;4x(x):xx-xx.].

Complications associated with pulsed field ablation versus radiofrequency catheter ablation of atrial fibrillation

BackgroundThe first commercial systems for pulsed field ablation(PFA) were recently approved by the Food and Drug Administration(FDA), but their safety profile in nationwide practice remains underexplored. ObjectiveThis study aimed to describe reported adverse events with PFA systems after their market release and to compare the relative proportion of complications associated with PFA versus radiofrequency(RF) ablation catheters. MethodsWe conducted a search of the Manufacturer and User Facility Device Experience database for adverse event reports involving FDA-approved PFA and RF catheters between January 1, 2024, to July 31, 2024. ResultsA total of 1,237 reports detailing clinical complications (N=156 for PFA and N=315 for RF) or catheter malfunctions (N=336 for PFA and N=430 for RF) were analyzed. The most common adverse events reported for PFA were pericardial effusion, vasovagal response, and hemolysis, and for RFA were pericardial effusion, ischemic stroke, and esophageal damage. The proportion of reported adverse events that were deaths was lower among PFA compared to RF (2.6% vs. 8.9%, P=0.010). Hemolysis (9.0% vs. 0%), coronary events (5.8% vs. 0.6%), and vasovagal responses (14.1% vs. 0%) were reported more frequently after PFA (all P<0.001). In contrast, esophageal damage (0% vs. 4.1%, P<0.001) and pulmonary vein stenosis (0% vs. 1.9%, P=0.184) were not reported with PFA, only with RF. Regarding catheter malfunctions, mechanical problems were reported in greater proportion after PFA compared with RF (87.2% vs. 17.2%, P<0.001). ConclusionThe reported complications associated with PFA and RF ablation differ significantly. Close attention to PFA-specific complications is essential for ensuring the safe use of PFA and for mitigating risk.

Understanding Variation Among Medical Device Reporting Sources: A Study of the MAUDE Database

BackgroundIncreasing medical device usage raises concerns regarding unexpected, potentially life-threatening events that pose public health risks. Such events are reported to the Food and Drug Administration (FDA), and cataloged in the Manufacturer and User Facility Device Experience (MAUDE) database, a vital tool for post market surveillance that requires information of high quality and integrity, particularly concerning reporting sources. PurposeTo analyze reporting behavior among different reporters, including manufacturers, distributors, and user facilities, by examining differences in reported factors, namely: (1) device types, (2) product problem attribution, and (3) selection of Device Problem Codes (DPCs) associated with the root causes of events. MethodsData spanning from 2005 to 2022 was retrieved from the MAUDE database using Python. Reports were grouped by reporter type and divided according to device type, and the reporter's indication of association with a product problem. Furthermore, events were classified by their respective DPCs, which were manually grouped into four categories: device issues, user issues, clinical issues, or unknown. FindingsThe analysis revealed significant variations among reporters across all examined aspects (P < 0.00001 in all comparisons according to the proportion test). Manufacturers predominantly focused on infusion pumps (10.1%) and Implant, Endosseous, Root-Form (IER) devices (7.6%), with a product problem indication rate of 29.2% in their reports. Device issues codes were the most frequently observed category in their reports, comprising 36.3%, followed by unknown codes (32%) and clinical codes (19.3%). Distributors, on the other hand, primarily reported on IER devices (89%) and exhibited the lowest product problem indication rate at 2.7%. Clinical issues codes predominated in their reports, constituting 85.7%, followed by unknown codes (6.7%). User facilities concentrated on intravascular sets (4.7%), Electrosurgical, Cutting & Coagulation & Accessories (4.2%), and Ventricular (Assist) Bypass (4.1%). Remarkably, their product problem indication rate was the highest at 56.7%. They predominantly reported device issues codes (54.3%), followed by use codes (30.8%), and unknown codes (11.4%) ImplicationsThe notable variation among different reporters underscores the importance of incorporating diverse sources when analyzing the database, particularly in cases where majority of reports originate from manufacturers. Decision-makers must approach database information comprehensively, considering data sources and diverse perspectives to inform regulatory decisions effectively. Developing strategies that encourage various reporters to contribute their unique and complementary viewpoints is advisable.

Device dislodgement and embolization associated with a new leadless pacemaker.

Currently, there are two approved single chamber leadless pacemakers (LP) in the United States (US), Micra VR™; approved since 2016 and AVEIR VR™; approved in 2022. A potential complication of LPs is dislodgement and/or embolization (D/E) during or after implant. According to the IDE trials, there appears to be a significant difference in D/E rates between the two LPs that have different fixation mechanisms; Micra uses nitinol tines, while AVEIR uses an active screw helix. The aim of this study was to determine if the AVEIR VR LP has continued to exhibit D/E in the United States since it was approved by the Food and Drug Administration (FDA) in April 2022. The FDA Manufacturer and User Facility Device Experience (MAUDE) database was searched for US D/E reports communicated by the manufacturers of both LP devices. For AVEIR VR we reviewed reports from approval till December 2023, and for Micra VR we looked at reports from approval to April 2024. Excluded were reports based on information indirectly obtained from registries, journals, social media, or volunteers. Total number of US implants was acquired from the manufacturers' product performance reports. During a period of 21 months, 5990 AVEIR VR implants had been registered in the United States, of which 53 (0.88%) encountered D/E both during and after the procedure. More D/E (32; 60.4%) occurred during the implantation procedure, with device release problems being the most prominent procedural issue involved with these events. Within a 8-year period, 72 237 Micra VR implants have been registered in the United States, of which 211 (0.29%) showed D/E. The rate of D/E since the US approval of both devices was significantly higher for AVEIR VR compared to Micra VR (0.88% vs 0.29%; p < .0001). AVEIR VR implants may be complicated by dislodgement with or without embolization. Currently, the estimated incidence is about 0.9%, which is significantly higher than Micra VR. Fixation issues and separation problems of the device from the delivery catheter appear to be responsible for most of these D/E events.

Measurement inaccuracy reported via the Manufacturer and User Facility Device Experience database for an implantable pulmonary artery pressure sensor: recalibration direction and magnitude results

Abstract Introduction Remote monitoring using an implantable pulmonary artery pressure (PAP) sensor (CardioMEMS HF system) in patients with heart failure (HF) has been consistently shown to reduce HF hospitalizations [1]. The success of this approach relies on the accurate measurement of diastolic PAP (dPAP) over time to allow early interventions such as diuretic intensification [2]. However, it remains unclear how the measurement accuracy changes over time after the initial calibration at the time of device implantation. Purpose This study aims to identify measurement inaccuracy events and to quantify the magnitude and direction of required device recalibration for CardioMEMS devices as reported in a large-scale regulatory device database. Methods We used the publicly accessible Manufacturer and User Facility Device Experience (MAUDE) data maintained by the US Food and Drug Administration (FDA). The summary search was performed for the CardioMEMS pulmonary artery pressure sensor for the entire product life cycle from January 2009 to February 2024 [3,4]. The entries related to the measurement accuracy under ‘Device Problems’ categories were obtained. Tested accuracy was reported to have been within ±10mmHg of a reference pressure measurement throughout simulated use for 10 years [5]. Normal range for dPAP is ~8mmHg to 15mmHg [6]. Results A total of 2656 entries were obtained. Following categories were identified for the reported entries: device sensing problem (N=999, 38%); incorrect measurement (N=1349, 52%); incorrect measurement, inappropriate waveform (N=279, 11%), and incorrect, inadequate, or imprecise results or readings (N=29, 1%). After excluding 56 entries for missing information, 2600 entries were included for the analysis. A total of 1676 (64%) entries reported the need for recalibration of the CardioMEMS device. A mean PAP difference (defined as the difference of the mean PAP reference value measured at the time of recalibration minus the CardioMEMS reading obtained during the reference measurement) is shown in Figure 1. Compared to the reference pressure values at the time of recalibration, 488 (29%) of CardioMEMS readings were higher and 1188 (71%) were lower. The absolute recalibration pressure difference was 14.5 ± 9.3 mmHg (mean ± standard deviation, range 0.02-59.3 mmHg). The recalibration by more than 10 mmHg was reported in 1040 (40%) entries. Conclusions Suspected measurement inaccuracy with CardioMEMS device is not uncommon and often necessitate recalibration. Almost one-half (40%) of the recalibrations required more than 10 mmHg correction. These results should inform clinicians to consider recalibration along the course of CardioMEMS monitoring if there is discordance between clinical assessment and the values from the device.Figure 1.Figure 2

A Retrospective Study of the Adverse Events Associated With Over-the-Counter Hearing Aids in the Manufacturer and User Facility Device Experience (MAUDE) Database

A Retrospective Study of the Adverse Events Associated With Over-the-Counter Hearing Aids in the Manufacturer and User Facility Device Experience (MAUDE) Database

Real-World Safety of Prostate Cancer Focal Therapy: MAUDE Database Analysis.

Objective: The aim of this study was to assess the real-world safety profile of medical devices used in focal prostate cancer treatment utilizing the Manufacturer and User Facility Device Experience (MAUDE) database. Methods: The MAUDE database was searched for reports on high-intensity focused ultrasound (HIFU), cryoablation, laser ablation, and irreversible electroporation (IRE) devices used in prostate cancer treatment from 1993 to 2023. Adverse events were identified and categorized. Results: We identified 175 reports for HIFU, 1362 for cryoablation, 615 for laser ablation, and 135 for IRE devices, with 28, 284, 126, and 2 respective reports, directly related to prostate cancer treatment. The aggregated data revealed the majority of complications were minor, with 82.5% (n = 363 out of 440 total complications) classified as Clavien-Dindo grade 1 or 2. Common minor complications included erectile dysfunction and urinary retention. Severe complications such as rectal fistulas were noted in HIFU and IRE treatments, along with singular mortality due to pulmonary embolism in cryoablation. Conclusions: Our analyses from MAUDE reveal that devices used in focal therapy for prostate cancer are predominantly associated with minor complications, underscoring their overall real-world safety profile. However, the occurrence of severe adverse events emphasizes the critical importance of rigorous patient selection and meticulous procedural planning. These findings provide valuable insights into the safety profile of focal therapy devices and contribute to the growing body of evidence on their use in prostate cancer treatment.

A comparison of procedure-related adverse events between two right ventricular leadless pacemakers.

The Medtronic Micra VR and Abbott AVEIR VR are the leadless pacemakers (LPM) currently available in the United States (US). Micra VR employs fixation tines and the AVEIR VR uses an active fixation helix. Micra VR requires fixation before electrical measurements are obtained, while R-waves may be mapped by AVEIR VR without fixation. Little comparative data is available for these LPMs. Accordingly, we compared the incidences of procedure-related major adverse clinical events (MACE) and device problems in the US for Micra VR and AVEIR VR during 2022-2024. We searched the FDA's Manufacturer and User Facility Device Experience (MAUDE) database for US reports of MACE and device problems that were filed from April 2022 to December 2023 for AVEIR VR, and from June 2022 to April 2024 for Micra VR. Totals for US-registered LPM implants were obtained from the manufacturers' product performance reports. During the study period, 5990 AVEIR VR and 10 940 Micra VR implants were registered in the US. We found 305 MAUDE reports for AVEIR VR (5.1%), versus 541 MAUDE reports for Micra VR (4.9%) (p = .702). The incidence of MACE was 0.72% (43/5990) for AVEIR VR versus 0.59% (65/10 940) for Micra VR, (p = .387). The incidences of procedure-related death, cardiac perforation. cardiac arrest, emergency pericardial drainage or reparative surgery were similar for both LPMs (p > .05). Micra VR had more unacceptable thresholds requiring LPM replacement compared to AVEIR VR (95;0.9% vs. 24;0.4%; p = .001). AVEIR VR had a statistically higher incidence of device dislodgement during (32) and after (21) implant compared to Micra VR (53 (0.9%) vs. 46 (0.4%), p < .001). Micra VR and AVEIR VR have similar procedural safety profiles, including the incidences of death and perforation. However, device problems differed significantly, possibly related to their design differences. Compared to Micra VR, AVEIR VR appears to have an advantageous threshold measurement capability but is more prone to device dislodgement.

Adverse Events of the Over The Scope Endoscopic Clips and Cutters: A MAUDE Database Analysis

The OVESCO® clip system, including the Over-The-Scope Clip (OTSC) and Full-Thickness Resection Device (FTRD), has demonstrated efficacy in managing various gastrointestinal pathologies. However, real-world data on device malfunctions and patient complications are limited. This study aimed to analyze adverse events associated with OVESCO® clips and cutters reported to the FDA Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database was searched for reports related to OVESCO® clips and cutters from January 1, 2007, to August 30, 2024. Event date, device type and model, manufacturer, event type, device problem, and patient complications were extracted. Descriptive statistics were used to summarize the findings. Forty-two reports were identified, with 41 involving OVESCO® clips and one involving an OVESCO® cutter. The most common device problem for OVESCO® clips was failure to deploy (61.0%), followed by unintended deployment or misfiring (17.1%). Gastrointestinal perforation was the most frequently reported patient complication (60%). The OVESCO® cutter report described device component breakage and foreign body retention. No clear trends in adverse event reporting were observed over the study period. OVESCO® clips and cutters are associated with potential device malfunctions and patient complications, particularly gastrointestinal perforation. The findings highlight the need for careful patient selection, meticulous technique, and close post-procedural monitoring. Collaborative efforts among stakeholders are essential to optimize device safety and efficacy. Continued post-marketing surveillance and real-world data analysis are crucial for monitoring the performance of endoscopic devices and improving patient outcomes.

Pulmonary Artery Injury Following Endocardial Left Atrial Appendage Occlusion: The Known and Unknown.

Left atrial appendage closure (LAAC) is frequent alternative for stroke prophylaxis in patients for whom oral anticoagulation is contraindicated. Pulmonary artery injury (PAI) is a feared yet rare complication of endocardial LAAC, but its surrounding literature is scarce. The aim of the current study was to review prior PAI published reports and the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to understand evidence and mechanisms of PAI after LAAC. A systematic review was conducted of the literature and MAUDE database for previously reported cases of PAI, and cases were reviewed for patient characteristics and outcomes. In addition, we identify risks and review our strategies to avoid this injury. Thirty-six cases (16 case reports and 20 MAUDE reports) of PAI were found. These patients had a mean age of 73.6 ± 8.2 years with a median CHA2DS2VASC score of 5 (quartile 1-quartile 3: 3-6). Most commonly, LAAC associated with PAI involved a dual-seal (75%) followed by lobular occlusive devices (19.4%); the device was unspecified in 2.8% of cases. PAI commonly presented postprocedurally, either within the first 24 hours (50%) or beyond (38.9%), with cardiac tamponade (61.1%) or cardiac arrest (19.4%). Overall, 52.8% required surgery with or without antecedent pericardiocentesis, and 16.7% were managed with pericardiocentesis. PAI was associated with a high mortality rate (ie,33.3%). Unfortunately, no specific cardiac imaging or procedural details to predict PAI were noted in the reports. Presentation of PAI after LAAC can occur immediately following the procedure or be delayed. Thus, the threshold for suspicion, especially with rapid and hemodynamically significant pericardial effusion, after LAAC should be low.

Embankment base strengthening and construction of working platforms on soft soil

Geosynthetics have been used for decades in infrastructure construction, especially in traffic construction and geotechnics. Despite this, there is still a relatively low uptake of methods for designing solutions using these materials. While the applications of geogrids (or more broadly: geosynthetics) in reinforced soil structures (retaining walls, steep slopes) and the associated design methods are well described in the literature and standards, there is much more modest knowledge available on applications related to the reinforcement of the subsoil directly under road and railway pavement structures, the construction of working platforms on soils with very low bearing capacity, or increasing the fatigue life of the pavement itself. This situation is due, among other things, to the fact that different geosynthetics, including different geogrids, affect the bearing capacity of the subsoil and the durability of the structure in different and often very different ways. Hence – unlike, for example, in the case of retaining walls – it is difficult to develop a one-size-fits-all design method covering this range of applications. It is necessary to rely on the experience of manufacturers of particular varieties of geogrids or geo-grids and to use design methods developed by them based on this experience. This article presents the technology of geocellular mattresses used primarily in the base of embankments on weak and deformable grounds, as well as for the construction of temporary working platforms. The performance of structures in complex and complicated geotechnical conditions is analysed on the example of completed projects. The results of back analysis of structures subjected to real-scale tests are presented, which can be used for preliminary analysis of solutions in numerical modelling programmes

Intragastric balloon adverse events: a comprehensive MAUDE database review

Background Endoscopic bariatric interventions are viable alternatives to traditional weight loss surgeries for patients with a body mass index between 30 and 40 kg/m2. While studies have explored the impact of intragastric balloons on obesity and weight reduction, comprehensive data on real-world device-related complications and failures are limited. This study aimed to investigate mechanical failures leading to patient adverse events reported to the US Food and Drug Administration. Methods A retrospective analysis using the Manufacturer and User Facility Device Experience (MAUDE) database examined device-related events and patient outcomes associated with various intragastric balloons from July 2017 to October 2023. Data analysis was performed using SPSS software to assess the reported events and their associations with specific types of intragastric balloons. Results Our review included 1393 cases, revealing 1758 device malfunctions and 1760 patient complications. Deflation problems (25.31%) and balloon leakage or rupture (21.90%) were the most common device-related complications. Patient complications were primarily linked to the Orbera balloon, with implant failure (24.30%), abdominal pain (21.92%), and vomiting (21.26%) as leading adverse events. Conclusion Our findings highlight the need for continuous surveillance, rigorous monitoring, and enhanced safety protocols for intragastric balloons.

Trends and incidence of reported events associated with ureteral stents: an analysis of the food and drug administration's manufacturer and user facility device experience (MAUDE) database.

Aim of this study is to summarize medical device reports (MDRs) between 2012 and 2022 relating to ureteral stents within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA). MAUDE was analyzed for all MDRs relating to each FDA-approved ureteral stent. Event descriptions were reviewed and characterized into specific event types. Outcome measures include specific ureteral stent and reported events as detailed by the MDRs. Data is presented as number of specific event/total events. Pooled Relative risk was used to compare data. 2652 reports were retrieved in 10 years and a progressive rise in reported events was recorded. 831/2652 (31%) were reported as injury while 1810/2652 (68%) as malfunction of the ureteral stent and 4 events of death. The most frequently reported adverse events (AEs) were stent break (627/2652: 23%); material problems (384/2652: 14%); calcification (222/2652: 8%); difficulty to insert, advance or remove the device (155/2652: 6%). Bard stents were associated with most material problems (19%), Resonance stents were associated with most difficulty to insert, advance or remove the device (9%) and calcification (15%) while filiform double pigtail stent set were associated with most breakage reports (56%) when compared to the other stents (PRR > 1, p < 0,05). According to MAUDE database the most frequent complications related to ureteral stents are breakage, material problems, calcification and difficulty to insert/advance/remove the device. As well Resonance ureteral stents seem to be associated with a higher risk of device problems.

How Often Does Technology Fail in Robotic-Assisted Arthroplasty? A Comprehensive Analysis of a United States Food and Drug Administration Database

BackgroundRobotic-assisted arthroplasty is a growing alternative to conventionally instrumented arthroplasty; however, the incidence of adverse events (AEs) associated with this technology reported to the United States Food and Drug Administration (FDA) remains poorly quantified. The objective of this study was to categorize AEs associated with robotic-assisted arthroplasty and calculate their annual incidence as reported to the FDA. MethodsThe FDA’s Manufacturer and User Facility Device Experience database was queried for AEs from January 1, 2017 to December 31, 2021 associated with the most prevalent robotic-arthroplasty system. The AEs were calculated using national surgical numbers provided by the manufacturer and grouped by total hip arthroplasty (THA), total knee arthroplasty (TKA), or partial knee arthroplasty (PKA). ResultsThere were 1,710 unique AEs across the study period, with 436 THA, 1,005 TKA, and 269 PKA, representing incidence rates of 0.37, 0.30, and 0.40%, respectively. All procedures demonstrated lower rates of AEs in the final year of the study, compared to the first year. Most complications were related to mechanical problems, not software issues. Surgical delays due to AEs occurred in THA (0.13% cumulative incidence, 14.0 minutes average delay), TKA (0.13%, 20.6 minutes), and PKA (0.22%, 19.4 minutes). No cases were canceled due to AEs in THA, though a few TKA (0.003%) and PKA (0.02%) cases were not performed. Patient injuries occurred in 0.05, 0.05, and 0.08% of THA, TKA, and PKA, respectively. Surgical reintervention was necessary in 0.004, 0.003, and 0.01% of THA, TKA, and PKA, respectively. ConclusionsRobotic-assisted arthroplasty has a small number and relatively low rate of AEs reported to the FDA as measured through the Manufacturer and User Facility Device Experience database, with rates steadily decreasing over the study period. Patient injury, case delay, and reoperation represent only a small fraction of the already rare AEs in the database.

Underreporting of complications following AF ablation: Comparison of the manufacturer and user facility device experience FDA database and a voluntary invitation-based registry: The POTTER-AF 3 study

BackgroundThe Manufacturer and User Facility Device Experience (MAUDE) database houses medical device reports of adverse events involving medical devices marketed in the United States submitted to the U.S. Food and Drug Administration (FDA) by mandatory and voluntary reporters. The MAUDE database is frequently used in clinical studies to report on device-related complications. Data about its efficacy are scarce. ObjectiveWe aimed to compare the mandatory MAUDE database (MAUDE group) with the invitation-based POTTER-AF study (POTTER-AF 1 group) regarding data quality, procedural characteristics, diagnosis, treatment, and survival. MethodsThe reports of esophageal fistula esophageal fistula following atrial fibrillation (AF) ablation in the MAUDE database were compared with those in the POTTER-AF study between August 1, 2009, and August 31, 2019. ResultsEsophageal fistulas were reported in 47 patients in the MAUDE group and in 81 in the POTTER-AF 1 group. Procedures were performed with radiofrequency, cryoenergy, or laser energy in 66.0%, 31.9%, and 2.1% (MAUDE group) and in 96.3%, 2.5%, and 1.2% (POTTER-AF 1 group). The median time to symptoms was 21 (14, 32.5) days (MAUDE group) and 18.0 (6.8, 22.3) days (POTTER-AF 1 group; P = .031). The diagnostic method was reported in 38.3% of patients in the MAUDE group and in 98.8% in the POTTER-AF 1 group, the treatment in 57.4% and 100%, and the outcome in all patients. In the MAUDE group, treatment was surgical (51.9%), endoscopic (37.0%), combined (3.7%), or conservative (7.4%), compared with 43.2%, 19.8%, 7.4%, and 29.6% in the POTTER-AF 1 group. Overall mortality was 76.6% in the MAUDE group and 61.7% in the POTTER-AF 1 group (P = .118). ConclusionIn the mandatory MAUDE database, fewer esophageal fistula cases were reported compared with an invitation-based study. The data quality in the MAUDE database was significantly poorer.

BNPLA: borated plastic for 3D-printing of thermal and cold neutron shielding

3D printing technologies such as fused filament fabrication (FFF) offer great opportunities to enable the fabrication of complex geometries without access to a workshop or knowledge of machining. By adding filler materials to the raw filaments used for FFF, the material properties of the plastic can be adapted. With the addition of neutron absorbing particles, filaments can be created that enable 3D printing of neutron shielding with arbitrary geometry. Two materials for FFF are presented with different mixing ratios of hexagonal Boron nitride (h-BN) and Polylactic acid (PLA). BNPLA25 with 25 %wt h-BN and BNPLA35 with 35 %wt h-BN are compared to the commercially available Addbor N25 material. To qualify the applicability of BNPLA25 and BNPLA35 as shielding material for neutron instrumentation, such as neutron imaging, we investigated the overall neutron attenuation, the influence of non-optimized print settings, as well as characterized the incoherent neutron scattering and the microstructure using neutron imaging, and time-of-flight small-angle-neutron-scattering. Finally, the tensile strength of the material was determined in standardized tensile tests. The measured neutron attenuation shows excellent agreement with analytical calculations, thus validating both the material composition and the calculation method. Approximately 6 mm (8 mm) BNPLA35 are needed for 1×10-3\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$1\ imes 10^{-3}$$\\end{document} transmission of a cold (thermal) neutron beam. Lack of extrusion due to suboptimal print settings can be compensated by increased thickness, clearly visible defects can be mitigated by 11–18% increase in thickness. Incoherent scattering is shown to be strongly reduced compared to pure PLA. The tensile strength of the material is shown not to be impacted by the h-BN filler. The good agreement between the measured attenuation and calculation, combined with the adoption of safety factor enables the quick and easy development as well as the performance estimation of shielding components. BNPLA is uniquely suited for 3D printing neutron shielding because of the combination of non-abrasive h-BN particles in standard PLA, which results in a filament that can be printed with almost any off-the-shelf printer and virtually no prior experience in 3D printing. This mitigates the slightly lower attenuation observed as compared to filaments containing B4C\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$${\\hbox {B}_{4}}\\hbox {C}$$\\end{document}, which is highly abrasive and requires extensive additive manufacturing experience.

Adverse events associated with robotic-assistance in total hip arthroplasty: an analysis based on the FDA MAUDE database.

The Food and Drug Administration (FDA) maintains the Manufacturer and User Facility Device Experience (MAUDE) database for reporting adverse events associated with medical devices, including emerging technologies, such as robotic-assisted total hip arthroplasty (THA). Aim of this study was to evaluate the variation of adverse events associated with robotics in THA. Medical device reports (MDRs) within the MAUDE database were identified between 2017 and 2021. For MDR identification the product class "orthopaedic stereotaxic equipment" and terms associated with THA were used. Individual adverse events were identified and organised by type and consequences, such as patient injury, surgical delay, or conversion to the manual technique. 521 MDRs constituting 546 discrete events were found. The most common reported complication was intraoperative hardware failure (304/546, 55.7%), among which the most common failure was a broken impaction handle/platform (110, 20.1%). Inaccurate cup placement was the second most common reported complication (63, 11.5%). Abandoning the robot occurred in 13.0% (71/521) of reports. A surgical delay was noted in 28% (146/521) of reports, with an average delay of 17.9 (range 1-60) minutes. Identifying complications that may occur with robotics in THA is an important first step in preventing adverse events and surgical delays. Database analysis provide an overview of the range of complications.