Experience Database Research Articles

Modes of failure of guide catheter extensions: Insights from the MAUDE database.

Guide catheter extensions (GCEs) are commonly used to facilitate percutaneous coronary interventions (PCIs). We investigated the incidence and modes of failure of GCEs.. Data from the Manufacturer and User Facility Device Experience (MAUDE) database between 2012 and 2022 were used to investigate the most common modes of failure and related adverse events with the use of GCEs. We performed analysis of 4 commonly used catheters: GuideLiner (Teleflex), Guidezilla (Boston Scientific), TrapLiner (Teleflex), and Telescope (Medtronic). The first event reported for GuideLiner was in 2012, Guidezilla in 2018, TrapLiner in 2017, and Telescope in 2019. During the study period, a total of 651 events were reported to the database. A total of 429 true GCE device failures were identified: 59 (14%) for GuideLiner, 297 (69%) for Guidezilla, 47 (11%) TrapLiner, and 26 (6%) for Telescope. Catheter detachment or fracture was the most frequently reported device failure for all 4 GCEs; these failures included shaft fractures, tip deformations, and collar detachments. We identified 222 reported events as unspecified adverse events; these events included device-to-device incompatibility, difficulty to advance, and device fractures outside the patient body. Only 58 (8.9%) events resulted in patient complication. Of these, coronary artery dissection was the most frequently reported complication. Device detachment/fracture is the most common mode of device failure in all 4 GCEs, and coronary dissection is the most common patient complication.

Deoxycholic Acid for Submental Convexity: A MAUDE Database Analysis

Study Design The study was a retrospective cross-sectional database analysis. Objective Deoxycholic acid (DOC) injections are a novel, in-office procedural alternative to submental liposuction or submentoplasty to address excess submental fat. Post-market safety data regarding this treatment is currently limited. The objective of this study is to analyze adverse events reported in the Manufacturer and User Facility Device Experience (MAUDE) database. Methods The MAUDE database was queried for all reports related to adverse events involving deoxycholic acid using the search terms “KYBELLA” and “deoxycholic acid.” Reports were individually reviewed by 2 reviewers and categorized with special attention to adverse events. Results A total of 34 medical device reports were identified from the database query. Thirteen of these reports (21 total events) were included in the analysis after excluding duplicates, unrelated adverse events, or events associated with the off-label use of DOC. Reported adverse events include excessive swelling (n = 5, 24%), marginal mandibular nerve weakness (n = 4, 19%), unsatisfactory aesthetic outcome (n = 4, 19%), numbness (n = 3, 14%), dysphagia (n = 1, 5%), infection (n = 1, 5%), and skin necrosis (n = 3, 14%). Two patients required hospitalization for skin necrosis management; both had underlying systemic diseases. Conclusions Adverse events following DOC injections included excessive swelling, dysphagia, numbness, infection, unsatisfactory aesthetic outcome, facial nerve weakness, and skin necrosis requiring hospitalization and/or surgery. Patient counseling regarding these adverse events should be discussed when offering DOC injections for submental convexity.

Cleaning of dental handpieces: Manufacturer and User Facility Device Experience database analysis and evaluation of in-use testing of manual and automated cleaning processes

BackgroundThis work aimed to provide evidence for the importance of regular cleaning and care of dental handpieces. In addition, this study aimed to show that automated cleaning of dental tools may deliver superior results compared with manual cleaning. MethodsPublicly available data from the US Food and Drug Administration’s (FDA’s) Manufacturer and User Facility Device Experience (MAUDE) database on incidents in the use of dental handpieces from the past 10 years were evaluated. The cleaning results of more than 4,830 instruments were also investigated and evaluated. ResultsBy evaluating the manufacturer’s information on the incidents reported in the FDA’s MAUDE database, the connection between inadequate or no maintenance and care and the incidents was clearly shown. The evaluation of the results of manual cleaning compared with automated cleaning clearly shows that better results can be achieved through automated cleaning. ConclusionsThe evaluation of the FDA’s MAUDE database confirmed and emphasized the importance of cleaning and care for the safe and long-term use of dental tools. Comparing the data from manual cleaning and the usage of a device for automated cleaning of dental handpieces, it was shown that the establishment of a quality-controlled system for in-use testing of cleaning performance could provide valuable data for assessing the efficacy of different cleaning processes. Valuable feedback for the user can be derived this way. In addition, it was shown that automated cleaning of dental handpieces is a reasonable alternative and leads to clearly better results.

Adverse Events in Total Artificial Heart for End-Stage Heart Failure: Insight From the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE).

Real-world clinical data, outside of clinical trials and expert centers, on adverse events related to the use of SyncCardia total artificial heart (TAH) remain limited. We aim to analyze adverse events related to the use of SynCardia TAH reported to the Food and Drug Administration (FDA)'s Manufacturers and User Defined Experience (MAUDE) database. We reviewed the FDA's MAUDE database for any adverse events involving the use of SynCardia TAH from 1/01/2012 to 9/30/2020. All the events were independently reviewed by three physicians. A total of 1,512 adverse events were identified in 453 "injury and death" reports in the MAUDE database. The most common adverse events reported were infection (20.2%) and device malfunction (20.1%). These were followed by bleeding events (16.5%), respiratory failure (10.1%), cerebrovascular accident (CVA)/other neurological dysfunction (8.7%), renal dysfunction (7.5%), hepatic dysfunction (2.2%), thromboembolic events (1.8%), pericardial effusion (1.8%), and hemolysis (1%). Death was reported in 49.4% of all the reported cases (n=224/453). The most common cause of death was multiorgan failure (n=73, 32.6%), followed by CVA/other non-specific neurological dysfunction (n=44, 19.7%), sepsis (n=24, 10.7%), withdrawal of support (n=20, 8.9%), device malfunction (n=11, 4.9%), bleeding (n=7, 3.1%), respiratory failure (n=7, 3.1%), gastrointestinal disorder (n=6, 2.7%), and cardiomyopathy (n=3, 1.3%). Infection was the most common adverse event following the implantation of TAH. Most of the deaths reported were due to multiorgan failure. Early recognition and management of any possible adverse events after the TAH implantation are essential to improve the procedural outcome and patient survival.

Real-world Experience Of Adverse Events And Modes Of Failure Related To The New Impella 5.5 - A Retrospective Analysis From Manufacturer And User Facility Device Experience Database

Real-world Experience Of Adverse Events And Modes Of Failure Related To The New Impella 5.5 - A Retrospective Analysis From Manufacturer And User Facility Device Experience Database

A review of adverse events related to synthetic cartilage implant for the first metatarsophalangeal joint: An analysis of Manufacturer and User Facility Device Experience database from 2016 to 2023

BackgroundThe Cartiva® Synthetic Cartilage Implant has been available in the United States since 2016. Despite promising early results in the treatment of first metatarsophalangeal joint osteoarthritis, literature reporting higher-than-anticipated rates of adverse events and catastrophic failure soon followed its widespread use. The purpose of this manuscript is to review all adverse events submitted for this device into the Manufacturer and User Facility Device Experience database. MethodsThe Manufacturer and User Facility Device Experience database was retrospectively reviewed between July 2016 and June 2023 for adverse events related to the Cartiva® Synthetic Cartilage Implant. Non-first metatarsophalangeal joint usage, duplicate submissions, and literature review reports were excluded. ResultsA total of 236 unique submissions were identified. The most common Device Problem was an Unspecified Device Issue (N=129, 55%). The most common Patient Problem identified was Pain/Inflammation (N=133, 56%). Implant removal occurred in 73.7% with an additional 9.3% pending removal. Of the 102 revision surgeries, 67.7% were converted to fusion. ConclusionAnalysis of the Manufacturer and User Facility Device Experience database submissions demonstrates that the Cartiva® Synthetic Cartilage Implant has continued dysfunction issues yet remains on the market. It represents the unfortunately repetitive rise and fall of new surgical devices accepted too early in the usage life cycle before mid- to -long-term outcomes exist. This raises questions about the utility of this database and about transparency by surgical device companies regarding their reported patient benefit-to-risk ratios. Based on our findings, we propose a restructuring of the Manufacturer and User Facility Device Experience database reporting rules. Level of evidenceIV, Case series from large database analysis ClassificationForefoot reconstruction

Real-World Experience With the Angio-Seal Closure Device: Insights From Manufacturer and User Facility Device Experience Database.

Angio-Seal (Terumo Medical Corporations, Somerset, New Jersey) device is indicated for femoral arteriotomy closure. Real-world published data on complications are limited. We present 1 year of safety events involving Angio-Seal from the US Food and Drug Administration's post-market surveillance database of Manufacturer and User Facility Device Experience (MAUDE). Steps for managing frequent device-related problems are discussed. Angio-Seal MAUDE data from November 2019 to December 2020 was classified according to (1) mode of device failure, (2) complication, (3) treatment, and (4) Cardiovascular and Interventional Radiological Society of Europe (CIRSE) adverse event classification system. There were 715 safety events, involving Angio-Seal VIP (93.1%), Evolution (5.7%), STS Plus (1.1%), and sizes 6F (62.5%) and 8F (37.5%). Failure mode involved unrecognized use of a damaged device (43.4%), failed deployment (20.1%), failed arterial advancement (6.3%), detachment of device component (4.9%), failed retraction (3.6%), operator error (1.1%), and indeterminate (20.6%). Of total, 44.8% of events were associated with patient harm. Complications involved minor blood loss (34.1%), hematoma (5.6%), significant blood loss (1.4%), and pseudoaneurysm (1.4%). Of total, 43.3% of cases required manual compression (MC), whereas 8.8% required more advanced intervention. Interventions included surgical repair (49.2%), thrombin injection (9.5%), balloon tamponade (6.3%), covered stent (4.8%), and unspecified (30.2%). Majority of safety events were CIRSE grade 1 (92.0%), followed by grades 2 (3.1%), 3 (4.6%), and 6 (deaths, 0.3%). Minority of devices were returned for manufacturer analysis (27.8%). The majority of safety events were associated with minor blood loss or local hematoma and could be addressed with MC alone. Most events were attributed to damaged device; however, very few devices were returned to manufacturer for analysis. This should be encouraged to allow for root cause analysis in order to improve safety profile of devices. System-level strategies for addressing barriers to under-reporting of safety events may also be considered. Our study highlights important safety events encountered in real-world practice with Angio-Seal closure device. The MAUDE database captures real-world device malfunctions not typically appreciated in conventional clinical trials. Our study provides valuable insight for clinician-users on anticipating and managing the most common device malfunctions. Additionally, our data provide feedback for manufactures to optimize product design and direct manufacturer user training to improve safety. Finally, we hope that the study promotes system-level strategies that foster reporting of safety events and undertaking of root cause analysis.

The burning truth about light therapy: a retrospective analysis of the MAUDE database on UV phototherapy and photodynamic therapy complications 2013-2023.

Phototherapy and photodynamic therapy (PDT) are ultraviolet light (UV) based therapies for patients with skin diseases, and are sometimes associated with potential adverse events (AE)s, including erythema, pain, pruritus, burns, and photoaging. We investigated UV phototherapy and PDT safety using the United States (US) Food and Drug Administration's (FDA)'s Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database, including medical device reports (MDR)s informed by voluntary and obligatory reporters since 1991, was searched for AEs associated with UV phototherapy and PDT 1/1/91-3/1/23. There were 59 UV phototherapy and 33 PDT related MDRs. Burns were the most common AE type for both phototherapy and PDT. The majority of phototherapy AEs occurred during 2021 (52.3%), and were significantly more likely to occur at home than in the clinic. Overall, 76.1% of MDRs associated with home light boxes were prescribed by online retailers, most of the MDRs (59.3%) mentioned that it is prohibited to sell phototherapy devices not prescribed by physicians, and only 8.5% noted poorly written home light box instructions. The COVID-19 pandemic prohibited in-person light treatments, and social distancing requirements may have resulted in increased frequency of home-based light treatments. Hence, while at home treatment may be easier and more accessible, in-office physician supervised UV treatments are associated with less frequent AEs. Moreover, some phototherapy MDRs reported poorly written instructions accompanying the home light box, and some PDT MDRs documented patients receiving inadequate education regarding the procedure. With the rise of at-home treatment options and the ease of obtaining devices on the internet, it is physicians' duty to advise patients against self-treating with home light boxes without prescribed treatment regimens and educate patients that are considering home phototherapy to ensure safer patient experiences.

Analysis of Adverse Event Reports in FDA’s MAUDE Database

Background and Objective: Medical devices (MDs) play a pivotal role in the modern healthcare environment. Adverse events are an expected part of an MD’s lifecycle. To prevent the recurrence of such events, various vigilance systems have been established worldwide. The Manufacturer and User facility Device Experience (MAUDE) database of the US Food and Drug Administration (FDA) is a publicly accessible database that contains data of medical device reports (MDRs) submitted to FDA since 1991. The aim of this study is to examine the evolution of MD adverse event reports and analyze several characteristic parameters, as they evolved during the last three decades.
 Material and Methods: An analysis of MAUDE data was performed to examine the outcomes and device characteristics of adverse event reports from 1991 up to 11/2022. These outcomes included the event type, remedial action, report source, reporter occupation and device evaluation by manufacturer. Specific MD groups were analyzed separately to examine their effect on the event outcomes. Segregated files of the database that contain different types of information on adverse event reports were combined to investigate the various aspects of these reports.
 Results: Event outcomes are presented as annual histograms. An overall of about 15 million reports have been submitted to MAUDE during the 30 years period examined with more than 2.5 million of them during the first 10 months of the year 2022. This number is growing at an increasing rate. Most of the events (63.5%) have resulted in simple device malfunction, without serious implications to the patient. Depending on the device type however, the health risks may be higher (98.4% injuries from specific dental implants and 3.2% deaths from implantable defibrillators). About 20% of the reports have led to recalls or other corrective actions. Most of the reports (96%) are submitted by manufacturers and over 70% of the devices returned to them are evaluated, following the requirements of FDA 21 CFR, 803. The reporter’s occupation was found to be related to the types of devices associated with the event. Finally, the average device age was found to be 4 years, with an increasing tendency observed over the years, while still most of the events occur during the first year of operation.
 Conclusion: A medical device adverse event reporting system is a critical component of safety in the use of medical technology in modern healthcare. The information available in MAUDE and its use continues to grow at an accelerated rate and allows critical improvements of MDs, especially in terms of risk prevention, as it gives perception about their safety issues. FDA has taken various steps to encourage and facilitate adverse event reporting and make the data available to the public.

Leadless pacemaker tine damage and fracture: novel complications of a novel device fixation mechanism

BackgroundLeadless pacemakers represent a paradigm-changing advancement. However, they required innovative and novel device design, including the use of nitinol tines for fixation. ObjectiveWe aimed to understand the potential for fracture in the novel tine-based fixation mechanism. MethodsA retrospective approach was used to search the Manufacturer and User Facility Device Experience (MAUDE) database for events related to Micra pacemaker tine fracture and damage. Review of each report was performed to ascertain frequency of tine fracture and damage. ResultsOf 4241 MAUDE reports (2104 Micra VR, 2167 Micra AV), 230 included the terms “fracture” or “tine”, which yielded 7 tine fractures and 19 reports of tine damage. Overall, 2/7(29%) tine fractures were noted during implant, whereas 2/7(29%) were discovered ≥1 week after implant; 5/7(71%) tine fracture reports described no associated patient signs or symptoms, and 4/7 (57%) described no change in pacing parameters. Tine damage occurred during implant in 16/19 (84%), compared with 2/19 (11%) noted ≥1 week after implant;15/19 (79%) tine damage cases reported no associated signs or symptoms, and 7/19 (37%) described no changes in pacing parameters. Among all cases, there was 1 case of device embolization. ConclusionsThe novel tine-based fixation mechanism appears susceptible to a novel failure mechanism – tine fracture and/or damage. Our analysis suggests these events may not always be associated with adverse signs or symptoms. Diligent attention at implant, and future bench or clinical studies are needed to understand the rate, clinical impact, and mechanism of such failures, and role of surveillance.

Adverse events related to triplanar 1st tarsometatarsal joint arthrodesis: 5-year analysis of the united states food and drug administration manufacturer and user facility device experience database

BackgroundThe Lapiplasty® 3D Bunion Correction™ system represents an instrumented, jig-guided system to facilitate performing triplanar 1st tarsometatarsal joint arthrodesis. Literature available for this system is positive, although the vast majority is from inventor/consultant surgeons. The purpose of this manuscript is to review adverse event submissions recorded in the Manufacturer and User Facility Device Experience database specific to this system. MethodsThe Manufacturer and User Facility Device Experience database was retrospectively reviewed from inception to 30 June 2023 for adverse events submitted for the Lapiplasty® 3D Bunion Correction™ system. Submissions that involved a medical device product other than this system, duplicate entries, and submissions with data extracted from already published literature were excluded. ResultsA total of 180 unique reports that met inclusion criteria during the 5-year period available were reviewed. The mean time between event occurrence and submission was 46.7-days. The most common entity submitting to the database were the manufacturer company representative or distributor in 66.4%. The most frequently encountered patient problems were pain in 41.9%, non-union in 18.2%, and hardware-related irritation in 11.7%. Reports that detailed a revision surgery described partial/complete hardware removal in 62.7% and revision with additional hardware implantation in 23.3%. ConclusionWhile no direct conclusions regarding the Lapiplasty® 3D Bunion Correction™ system can be drawn from the data as it consists of only adverse event reports, this study demonstrates the need for more non-inventor/consultant literature to further investigate adverse events related this particular system.

LARIAT or AtriClip: Complications Profile and Comparison in Patients with Atrial Fibrillations Based on Manufacturer and User Facility Device Experience Database.

Background and Objectives: Left atrial appendage closure is an alternative treatment to reduce thromboembolism in patients with atrial fibrillation in whom oral anticoagulation (OAC) is contraindicated. The aim of this study was to evaluate the complications profiles of the LARIAT and AtriClip devices and perform a comparison between them based on the MAUDE (Manufacturer and User Facility Device Experience) database. Materials and Methods: The Manufacturer and User Facility Device Experience database was searched on 15 January 2023. For AtriClip, only reports regarding isolated procedures or procedures associated with minimally invasive ablation were included. Adverse effects and causes of death were defined based on the literature on the topic and the causes described in the reports. In total, 63 patients were included in the LARIAT group and 53 patients were included in the AtriClip group. Results: With the LARIAT device, the most common complication without device problems was pericardial effusion (n = 18, 52.9%), whereas this complication was not observed with AtriClip (p < 0.001). Postoperative bleeding was a second complication that occurred significantly more often in the LARIAT group-in 15 (44.1%) cases versus 1 (2.7%) case with AtriClip (p < 0.001). In addition, significant differences were found in the prevalence of stroke (LARIAT n = 0 vs. AtriClip n = 7, 18.9%, p = 0.012) and thrombus (LARIAT n = 2, 5.9% vs. n = 11, 29.7%, p = 0.013). Conclusions: Each type of left atrial appendage closure procedure is associated with device-specific requirements and complications that, if known, can be avoided.

Polyether Ether Ketone (PEEK) Implants and the Manufacturer and User Facility Device Experience (MAUDE) Database: An Updated Review of Adverse Events and Complications.

Polyether ether ketone (PEEK) custom implants have been fundamental in addressing bone malformations and restoring traumatic defects within the field of craniofacial surgery. Although such implants are generally considered safe and appropriate alternatives to autologous bone grafts, there has been a lack of standardized reporting of adverse events associated with PEEK implants. The purpose of this study is multi-fold: (1) to explore the current landscape of autologous and allogeneic materials utilized for bone grafting; (2) to analyze and characterize adverse events associated within PEEK implants from the widely accredited, FDA-run database, Manufacturer and User Facility Device Experience (MAUDE); and using the data, (3) to provide guidance to craniofacial surgeons using PEEK implants in their surgical practice. A retrospective review of the adverse events associated with PEEK implants were performed through the FDA-run database, Manufacturer and User Facility Device Experience (MAUDE). The database was surveyed from July 2013 to January 2023. Event types were categorized by injury or malfunction, and device-reported adverse events were recorded, respectively. Database search initially yielded 77 adverse event reports, but after duplicates were removed, 69 event reports were included in the analysis. These events were sorted into the following categories: device-related and patient-related. Event types were categorized by injury (48.3%) or malfunction (53.6%). The most common reported device-related adverse events were "Poor Fit" (53.6%) and "Adverse Event without Identified Use or Problem " (26.1%). The most common reported patient-related event was "Infection" (32.8%). Of these adverse event reports, 14 (20.2%) patients required a second surgery; 21(30.4%) required implant modification whereas in the operating room; 17 (24.6%) underwent implant removal. Nine (13%) patients experienced operative case delays due to implant modifications. Infection and poor fit were among the most commonly reported adverse events associated with PEEK customizable implants. Although PEEK implants have been widely implemented in addressing craniofacial bony defects, our database analysis does call for further investigation in studying the long-term outcomes associated with PEEK craniofacial implants. With such analyses and collaboration among plastic surgeons and device engineers, there is great opportunity for innovation of these devices.

Complications of eustachian tube balloon dilation: Manufacturer and User Facility Device Experience (MAUDE) database analysis and literature review.

To provide an analysis of complications following eustachian tube balloon dilation as well as their treatments and outcomes. PubMed, Ovid Embase, and MAUDE Database. A systematic approach following PRISMA guidelines was used to identify publications pertaining to balloon dilation of the eustachian tube from PubMed and Ovid Embase databases was used. Once these publications were critically reviewed, the primary outcome extracted were reported complications. Additional complications were collected in the Manufacturer and User Facility Device Experience (MAUDE) database using the product class "eustachian tube dilation device" and searching through relevant manufacturers. Complications and outcomes were compared between these sources. Fifty five full-length manuscripts involving 7155 patients were included and 98 complications reported for a 1.4% complication rate. The most frequently reported adverse events were subcutaneous emphysema of the head and neck (19%), epistaxis (12%), and acute otitis media (11%). The MAUDE search returned 18 distinct patient entries, of which 12 (67%) reported complications. The most reported complications in the MAUDE database included subcutaneous emphysema (8, 67%) and pneumomediastinum (3, 25%). The most serious complication was a carotid artery dissection reported in one patient in the MAUDE database. Eustachian tube dilation is rarely associated with complications, which nevertheless may lead to morbidity and medical emergencies. Patients and providers should recognize potential risks associated with this intervention as well as methods to manage complications.

Failure to defibrillate or cardiovert due to premature truncation of biphasic shocks from implantable defibrillators

BackgroundIn 2022 and 2023, Medtronic recalled implantable defibrillators because they may deliver less than full-energy shocks. The 2022 problem truncates the second phase of the waveform (SCP-T2), resulting in ∼32-J shocks, and is mitigated by downloadable software. The 2023 malfunction truncates the first phase of the waveform, resulting in 0- to 12-J shocks due to a glassed feedthrough problem (GFT-T1) that might be avoided by programming B>AX shock polarity. ObjectiveThe purpose of this study was to assess the consequences of GFT-T1 and SCP-T2 shocks in the Food and Drug Administration’s Manufacturers and User Facility Device Experience (MAUDE) database and to estimate the incidences of GFT-T1 and SCP-T2. MethodsWe analyzed MAUDE reports supplemented by Medtronic data; lead failures were excluded. The incidences of SCP-T2 and GFT-T1 were estimated using USA volumes for devices with glassed feedthroughs. ResultsOne hundred thirty-two devices delivered truncated shocks: 27 (20.5%) were GFT-T1; 103 (78.0%) were SCP-T2; and 2 (1.5%) truncated both phases (BOTH-T1&2). Of 54 ventricular fibrillation (VF) patients, 21 (38.9%) were not defibrillated by truncated shocks: 8 (38.1%) received GFT-T1 shocks, 12 (57.1%) received SCP-T2 shocks, and 1 received a BOTH-T1&2 shock; 2 patients suffered unrelated deaths; 1 was externally rescued; 1 outcome was unknown; the others were defibrillated by subsequent shocks or terminated spontaneously. The majority of patients (79.1%) shocked for ventricular tachycardia (VT) were converted, primarily (94.1%) by SCP-T2 shocks. Estimated incidences of GFT-T1 and SCP-T2 were 0.0078%–0.0088% and 0.1062%–0.1110%. ConclusionGFT-T1 and SCP-T2 shocks can result in failure to terminate VF/VT, but they may be preventable. Although the incidences of these truncated shocks are very low, heightened surveillance is warranted.

Abstract 15366: Quantification of Recent Reporting Rates of Atrioesophageal Fistula After Left Atrial Ablation for the Treatment of Atrial Fibrillation

Introduction: Atrio-esophageal fistulas (AEF) are a feared and fatal complication of left atrial ablation for the treatment of atrial fibrillation (AF). The recent POTTER-AF survey suggests that AEFs continue to occur despite best efforts to prevent them. A quantification of recent incidence rates and outcomes of AEF reported to the Manufacturer and User Facility Device Experience (MAUDE) database of the U.S. FDA may further elucidate trends in this complication. Research Question(s): What are the recent trends in reporting rates of AEF, and what are the outcomes? Purpose: To quantify the number of AEF reports as well as any reported outcomes of atrioesophageal fistulas and determine any trends over the last 4 years. Methods: We reviewed data from the Manufacturer and User Facility Device Experience (MAUDE) database for complications under the category of fistula that occurred over the last 4 years (2019 to 2022 inclusive). Reports were reviewed for any descriptions of outcome, and narratives were compared in an attempt to identify and exclude any duplicate reporting. Results: In total, three product codes resulted in 121 reported AEFs. Of these, 50 (41%) were listed as fatal. When provided, the time frame of death ranged from 12 days to several weeks after the index procedure. Product codes reporting AEFs included LPB (88 cases), OAE (22 cases), and OAD (11 cases), with codes representing cardiac ablation catheters and radiofrequency generators. Incidence by year showed a generally increasing trend (21 in 2019, 22 in 2020, 41 in 2021, and 37 in 2022, Figure 1). Conclusion: The annual rate of reported AEFs has not decreased over the last 4 years, and instead shows a generally increasing trend. Reported fatality rates remain high at 41%.

Abstract 13319: The Barostim Baroreflex Activation Therapy System: Safety Insights From FDA MAUDE Database

Introduction: BAROSTIM NEO® is a Baroreflex activation therapy (BAT) system which has been approved recently by FDA for patients with refractory heart failure. Post market experience of BAT related complications and performance issues have not been reported. Objective: To analyze the post-approval device failures and patient related adverse events (AE) associated with Barostim NEO® system using Manufacturer and User Facility Device Experience (MAUDE) database. Methods: A MAUDE database search was conducted on December 7, 2022, for reports received between Jan 1, 2019, to November 30, 2022. Manual search of the MAUDE database conducted using the term “Barostim” in the brand name section. The AE were adjudicated to various categories based on the review of the event description for each medical device report (MDR). Results: A total of 22 events were reported which included MDRs reported by physicians or manufacturer or both. Device related malfunction was reported in 45.5% (n=10) whereas patient related AE reported in 77.3% (n=17) cases. Of total device related AE, material split, cut or torn was most commonly reported problem (32%, n=7), followed by high impedance (13.6%, n=3) and low impedance (9.1%, n=2). Of the patient related AE, 32% (n=7) were related to clinical or subclinical infection, 18.2% (n=4) hematoma, 13.6% (n=3) heart failure or myocardial injury, 9.1% (n=2) stroke/CVA, 9.1% and 9.1% (n=2) twiddler’s syndrome. No carotid artery or jugular injury and procedure related death reported in the study period. The report is limited by the lack of information on the total number of BAT devices implanted across the country. Conclusions: This study provides a wide range of device malfunction and patient related post-approval adverse events for Barostim device which have not been reported in any clinical trial/study before. The reported complications seem to be in line with other cardiac implantable electronic devices and no BAT specific complications were noted.

Characterizing complications associated with skull clamps: A review of the manufacturer and user facility device experience database

ObjectiveHead immobilization with skull clamps is a prerequisite of many neurosurgical procedures. Adverse events relating to the use of skull clamps have been reported, however, given the paucity of published reports, we sought to conduct a more comprehensive analysis using the Manufacturer and User Facility Device Experience (MAUDE) database. MethodsThe MAUDE database was queried for neurosurgical skull clamp events over a 10-year period between January 2013 and December 2022. Reports were qualitatively analyzed and categorically assigned by the study authors as ‘mechanical failure,’ ‘slippage,’ ‘contamination,’ ‘insufficient information,’ and ‘other.’ Patient injury reports were also classified as ‘abrasion,’ ‘laceration,’ ‘hematoma,’ ‘fracture,’ ‘intracranial hemorrhage (ICH),’ ‘other,’ ‘insufficient information,’ and ‘death.’ ResultsOf 3672 reports retrieved, 2689 (73.2%) were device malfunctions, with mechanical failure (50.7%) and slippage (47.7%) being the most common causes. There were 983 reports (26.8%) involving patient injury which included lacerations (n = 776, 78.9%), fractures (n = 24, 2.4%), abrasions (n = 23, 2.3%), hematomas (n = 7, 0.71%), ICH (n = 3, 0.31%), and other causes (n = 6, 0.61%). Five (0.1%) deaths due to skull clamp related complications were also reported. ConclusionsThis study provides a more comprehensive picture of adverse events in neurosurgical procedures relating to the use of skull clamps. Mechanical failures of device parts were the most common device-related complication, and lacerations the most common adverse patient-related event. While more severe patient-related events were reported, they are relatively rare. The MAUDE database is useful for characterizing underreported device-related and patient-related adverse events.

Time-Varying Topology Formation Reconfiguration Control of the Multi-Agent System Based on the Improved Hungarian Algorithm

Distributed time-varying formation technology for multi-agent systems is recently become a research hotspot in formation control field. However, the formation reconfiguration control technology for agents that randomly appeared to fail during maneuvers is rarely studied. In this paper, the topological relations between intelligence are designed by graph theory to simplify the cooperative interaction between multi-agent systems. Moreover, this paper constructs the time-varying configuration of the target formation based on the rigidity graph theory and leader–follower strategy. Drawing on the establishment of the expert experience database in a collaborative process, we innovatively propose the establishment of a graphic library to help the multi-agent system quickly form an affine transformation as soon as it is disabled. Secondly, the improved Hungarian algorithm is adopted to allocate the target point when the first failure occurs. This algorithm incorporates a gradient weighting factor from the auction algorithm to improve the speed of system reconfiguration with minimum path cost. On this basis, a distributed multi-agent control law based on consistency theory is established, and the system’s stability can be guaranteed via Lyapunov functions. Finally, the simulation results demonstrate the feasibility and effectiveness of the proposed formation reconfiguration control algorithm in a collaborative environment.

Adverse Events of Femtosecond-Assisted Laser-Assisted In situ Keratomileusis: A Manufacturer and User Facility Device Experience Database Study.

To analyze the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database, which contains reports of adverse events involving medical devices, and characterize the most common adverse events of femtosecond (FS) laser-assisted in situ keratomileusis (LASIK). The MAUDE database was queried on May 19, 2022, for adverse events involving the ophthalmic FS laser reported from January 2012 to April 2022. Reports unrelated to LASIK procedures were excluded. Data extraction was performed on these reports, including the type of adverse event and whether surgery was successfully completed. Frequency analysis was performed using the Statistical Package for the Social Sciences. From the 3491 reported adverse events involving the FS laser system, 1136 met the inclusion criteria. Of the 672 cases where outcomes were reported, 476 were successfully completed and 196 were aborted. The most common intraoperative complications were incomplete cut (42.8%), thinner than intended flap (17.6%), and difficulty lifting the flap (12.0%). FS-related complications included opaque bubble layer (2.3%), air bubbles in the anterior chamber (2.4%), and vertical gas breakthrough (4.1%). Other device-related intraoperative complications included suction loss (10.2%), difficulty docking (2.4%), and laser malfunction (2.0%). The most common postoperative complications were diffuse lamellar keratitis (DLK) (7.8%) and rainbow glare (4.6%). The most common intraoperative FS-assisted LASIK complication in the MAUDE database was an incomplete flap. The most common postoperative complication was DLK. This study is the first to investigate FS-assisted LASIK adverse events in the MAUDE database. It can raise awareness of real-world surgical complications and help ophthalmologists better counsel and treat patients.