Drug Administration Manufacturer Research Articles

Adverse events associated with AXIOS stents: Insights from the manufacturer and user facility device experience database.

ABSTRACTBackground and Objectives:The AXIOS stent is indicated for transgastric or transduodenal drainage of symptomatic pancreatic pseudocysts and symptomatic walled off necrosis. The AXIOS stent functions as a conduit which allows solid and liquid pancreatic fluid collections (PFC) contents to pass into the luminal GI tract and also allows the passage of standard and therapeutic endoscopes into the PFC to perform endoscopic debridement. We aim to investigate the number and type of complications associated with AXIOS stents.Materials and Methods:We analyzed postmarketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database January 2016 to February 2021.Results:During the study period, approximately 588 reports with 579 device issues and 250 patient complications were identified. Most device complications were due to stent positioning problems or stent malpositioning (n = 206; 35.6%), followed by stent migration (n = 72; 12.4%), premature deployment (n = 61; 10.5%), material integrity (n = 56; 9.6%), deployment failure (n = 47; 8.1%), and difficulty removing the stent (n = 45; 7.7%). The most reported patient adverse events were hemorrhage/bleeding (n = 81; 32.4%), perforation (n = 26; 10.4%), pain (n = 22; 8.8%), unspecified infection (n = 20; 8.0%), and death (n = 17; 6.8%).Conclusions:Findings from the MAUDE database highlight patient and device complications which endoscopists should be aware of before AXIOS stent placement.

Exploring Adverse Events and Utilization of Topical Hemostatic Agents in Surgery.

Background and Objectives:This retrospective study provides preliminary qualitative assessment of the adverse events (AEs), focusing on pelvic and abdominal AEs and patient outcomes reported for three hemostatic agents used in gynecologic surgery.Methods:Utilization rates for oxidized regenerated cellulose powder (ORC), polysaccharide powder (PSP), and fibrin sealant solution (FSS) were obtained from hospitals via the Premier Healthcare databases for all surgical procedures from January 1, 2018 to September 30, 2020. All reported cases were extracted from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for ORC and PSP and from the FDA Adverse Event Reporting System (FAERS) database for FSS. Distributions of AEs by anatomical site (MAUDE/FAERS) and surgical procedures by specialty (Premier) were evaluated for each product. Number of cases and number and types of AEs were compared to the total utilization for each product.Results:PSP was the most used product during the period analyzed (n = 126,509 uses), followed by FSS (n = 80,628 uses), and ORC (n = 41,583 uses). Distribution of surgical procedures by anatomical site varied significantly between hemostatic agents (p < 0.001). ORC was associated with more patient cases with AEs and numbers of reported AEs compared with PSP and FSS (p < 0.001). ORC was associated with higher number of infections than PSP (p < 0.001) and FSS (p < 0.001).Conclusion:These findings suggest that ORC use in abdominal and pelvic surgery may result in more postoperative complications compared with non-ORC hemostatic agents. Further prospective randomized studies are needed to compare efficacy and safety of these products.

Complications associated with Dermabond® during head and neck surgery: MAUDE and literature review

IntroductionDermabond® is a liquid surgical sealant containing 2-octyl-cyanoacrylate that has been widely used during head and neck surgeries. This study aims to provide a summary of adverse events related to Dermabond® in head and neck procedures as reported in the MAUDE database, and to report a complete overview of all documented adverse events related to Dermabond® use in current literature. MethodsThe US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of adverse events related to Dermabond® use from January 1, 2010, to February 1, 2020. Data were extracted from reports pertaining to head and neck procedures. In addition, literature review was performed from January 1970 to January 2021. Various adverse events related to Dermabond® were included in the study. ResultsWe identified 32 adverse events, from which 29 (90.6%) were patient-related events and 3 (9.4%) were operator-related events. Of the patient-related events, contact dermatitis (CD) (20 [69.0%]) was the most common, followed by wound dehiscence (4 [13.8%]). All of the operator-related events were from inadvertent cut injury (3 [100%]). Following the literature review, adverse events of Dermabond® were categorized into CD, wound dehiscence, infection, and cut injury. ConclusionDermabond® demonstrated utility in various surgical procedures including head and neck surgeries but are associated with risks. This study identified adverse events associated with Dermabond®. Further studies are needed to establish the causation of contact dermatitis in certain populations.

Adverse Events Associated With Ossicular Prostheses: Utility of a Federal Database.

Ossicular prostheses have demonstrated utility in ossicular chain reconstruction, but their use also is associated with complications. This study aims to explore the utility of the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database for the systematic analysis of complications associated with ossicular prostheses. It also summarizes adverse events to patients (AEPs) and device malfunctions (DMs) reported in the MAUDE database, and attempts to examine the consequences brought about by these events and to identify likely root causes. Retrospective analysis of the MAUDE database. The MAUDE database was queried for reports from January 2010 to May 2020. Data were extracted from reports involving the use of ossicular prostheses. Seventy-three medical device reports, reports submitted to the Food and Drug Administration detailing suspected device-associated malfunctions, injuries, and deaths, involved ossicular prostheses and were included for analysis, from which 126 adverse events were extracted. Of these, 50 (39.7%) were AEPs, while 76 (60.3%) were DMs. The most common AEPs were foreign body and hearing loss, while the DMs reported most commonly were broken prosthesis and displaced prosthesis. Of the 76 DMs, 19 (25%) were attributed to mishandling by the operator, while 6 (7.9%) were due to a defective device. Broken prosthesis was the DM most commonly attributed to mishandling by the operator in 16 (32.7%) cases. Ossicular prostheses are used extensively for ossicular chain reconstruction, but also are associated with adverse events. The MAUDE database in its current form does not appear sufficient for the systematic review of adverse events associated with ossicular prostheses. A more standardized reporting format with clearly defined categories and inclusion of relevant variables might improve the quality of information provided by the MAUDE database.

Adverse Events With Intravascular Lithotripsy After Peripheral and Off-Label Coronary Use: A Report From the FDA MAUDE Database.

Currently only the peripheral intravascular lithotripsy (IVL) device is approved for use in the United States. We queried the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database from January 1, 2016 to December 14, 2020 for all reports of adverse events and modes of failure related to the peripheral IVL device, when used for on- and off-label indications. There were 20 reports of use in peripheral artery disease interventions and 3 reports of off-label use in coronary interventions. Device malfunction in 13 of 23 patients (56.5%) was the most common adverse event reported. Partial balloon or catheter dislodgment was the most common mode of IVL device failure in 12 of 20 patients (60%), followed by balloon rupture in 3 of 20 patients (15%). Coronary use was rare, and associated with balloon perforation in 1 of 3 patients, bradycardia in 1 of 3 patients, and aortocoronary dissection in 1 of 3 patients. In summary, IVL use carries risk of complications; hence, continued vigilance and postmarketing monitoring are warranted.

Adverse Events and Complications Associated With Intrathecal Drug Delivery Systems: Insights From the Manufacturer and User Facility Device Experience (MAUDE) Database

Modern intrathecal drug delivery systems (IDDS) are technologically advanced to deliver medication through various automated and patient-controlled programs. They also are associated with unique complications ranging from post-operative complications, medication-related adverse events (AE), device malfunction, to refill associated AE. To systematically analyze real-world complications and AE reported on the Food and Drug Administration's Manufacturer and User Facility Device Experience database (MAUDE) associated with IDDS among patients predominantly with chronic pain disorders. MAUDE database was sampled for a month four times a year during the study period, February 2018 to February 2019. The database was resampled every six months till August 2020 to evaluate for any additional reported cases during the index months. The two FDA approved IDDS, were included. AE were broadly classified into causes related to catheter malfunction, pump malfunction, biologic, and medication-related AE. A total of 1001 reports were included in the final analysis. The top three reasons for adverse report are infection/erosion (15.7%, n=157), motor stall (12.4%, n=125) and adverse medication reactions (11.8%, n=119), respectively. There were five deaths among patients with IDDS. Epidural hematoma (n=3) after IDDS surgery resulted in a death and residual neurological deficits after surgical evacuation. Programming errors, medication concentration discrepancy, and failure to turn on the pump after reprogramming are various preventable causes of medication-related IDDS AEs. Analysis of AE associated with IDDS from the MAUDE database provided a real-world perspective different from reported registry complications. Awareness and vigilance of preventable IDDS-related complications is the first step toward mitigating risks to provide safe and effective intrathecal drug delivery for chronic pain management.

Ultrasonic Device Complications in Endodontics: An Analysis of Adverse Events From the Food and Drug Administration Manufacturer and User Facility Device Experience.

The author conducted a study to determine the frequency and types of adverse events associated with endodontic ultrasonic devices as reported to the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. Endodontic ultrasonic device-related adverse events reported to the MAUDE database from January 1, 2016, to October 31, 2020, were accessed and reviewed. A total of 1258 adverse event reports were submitted to the FDA MAUDE database, as classified under FDA product code ELC (ultrasonic scaler) during the study period. Among these reports, 403 were specific to the dedicated use of the 2 main types of ultrasonic devices used in endodontic treatment: ultrasonic tip devices and irrigation-related devices. Device malfunction-associated events, consisting primarily of device breakage, comprised 393 of the 1258 adverse event reports, whereas the remaining 10 reports were identified as being patient injury-related reports. The frequency, root causes, and economic costs of ultrasonic tip device breakage remain largely unstudied. Ultrasonic endodontic device-related adverse events and patient injuries occurring within clinical practice may be underreported at the present time. Consequently, the risks and ultimate impacts to patients from ultrasonic endodontic device breakage, malfunction and unknown cause-related adverse events, and patient injuries during their clinical usage remain largely unknown at the present time. Eight of the 10 patient injury-related reports made to the FDA MAUDE database during the period under study, containing descriptions of varying degrees of injury severity, were associated with an irrigation-related device.

A Review of Reported Adverse Events in MRI-Safe and MRI-Conditional Cochlear Implants.

This study looks to examine how the development of diametric magnet cochlear implant devices (CIDs) has affected observed magnetic resonance imaging (MRI)-related adverse events and MRI safety measures. A search of the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was conducted using the product code "MCM" for "Cochlear implants." Reports were included for analysis if they involved MRI in recipients of cochlear implantation. Included reports were stratified into two cohorts by year: 2010 to 2014 and 2015 to 2020, reflecting the FDA approval of diametric magnet cochlear implants in 2015. Extracted event variables included implant manufacturer, adherence to MRI protocol, patient injuries, and device malfunctions. The product code search query yielded a total of 27,305 reports, from which 584 reports were included for analysis. From 2010 to 2014, there were 109 adverse events and 30 pre-MRI explantations. Implant displacement was the most common device malfunction (n = 69, 87.3%), and pain was the most common patient injury (n = 16, 53.3%). From 2015 to 2020, there were 566 adverse events and 62 pre-MRI explantations. The most common device malfunction was implant displacement (n = 365, 94.6%) and pain was the most common patient injury (n = 114, 63.3%). Only 64/114 (56.1%) reports after 2015 reported adherence to the recommended MRI protocol. No adverse events occurred in patients with synchrony diametric-magnet CIDs. Despite the advent of FDA-approved MRI-safe diametric magnet devices, implanted patients are still experiencing injury, explantation, and device malfunction, and providers are reporting poor compliance with MRI safety protocols.

Contemporary post-marketing adverse events and modes of failure related to VASCADE Vascular Closure System: The utility of the MAUDE database.

To analyze post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for the VASCADE Vascular Closure System (Cardiva Medical Inc., Santa Clara, CA). The VASCADE Vascular Closure System is a closure device for femoral arterial and venous access-site closure that was approved by the FDA in 2013. However, post-marketing data and experience on the most commonly reported complications and modes of failure associated with the VASCADE Vascular Closure System are limited. Post-marketing surveillance data from the FDA MAUDE database from October 2013 through March 2020 were analyzed, yielding 201 reports. Of the 201 reports of major complications involving VASCADE devices, 156 reports involved either injury (145) or death (11) related to the device. Of the 145 injury reports, bleeding was the most common adverse outcome described (85), followed by pseudoaneurysm (29) and pulselessness of an extremity (21). The device malfunction incidents (41 reports) were reported in three main categories, with deployment failure being the most commonly reported complication. Our analysis of the MAUDE database demonstrates that in contemporary post-marketing practice, physicians should be well-trained and educated to use the VASCADE closure device because improper utilization is a common cause of device failure, and complications with the VASCADE device can have profound clinical implications.

Malfunction Events in the US FDA MAUDE Database: How Does Robotic Gynecologic Surgery Compare with Other Specialties?

To review malfunction events (MEs) related to the use of the da Vinci robot reported to the United States Food and Drug Administration Manufacturer and User Facility Device Experience in the last 10 years and compare gynecologic surgery with other surgical specialties. A retrospective review. Manufacturer and User Facility Device Experience database. Reports from 2010 to 2020 with keywords "Davinci" and "Intuitive". Report review. There were 679 reports included in the final analysis. Most MEs occurred intraoperatively (81.7%) and were related to robotic instrument malfunction (84.5%), and 30% required an instrument switch to complete the procedure. Conversion to open and laparoscopic surgery was required in 3.1% and 1.3% of MEs, respectively. Injury to the patient occurred in 15.6% of MEs. Of the reported injuries to patients, 6.6% were related to robotic malfunction, 49.2% to instrument malfunction, and 18% to surgeon or staff misuse of the robotic system, and 15.6% were complications inherent to the procedure, not related to the robotic system. Of all the reported MEs, 4.4% were related to robot malfunction, 1.5% to console malfunction, 73.3% to Intuitive accessory malfunction, 11.2% to other accessory malfunction, 4% to surgeon or staff misuse of robotic system, and 3% to complications inherent to the procedure. Comparison between gynecologic surgery and other surgical specialties showed that 14.4% of issues were solved intraoperatively in gynecologic surgery vs 13.7% in other specialties (p=.185). The procedure was completed robotically in 85.2% in gynecologic surgery vs 84% in other specialties, laparoscopically 4.6% vs 3.7%, and open in 10.2% vs 12.4%, respectively (p=.883). In gynecologic surgery, reported MEs were made by patients in 14.8% vs 4.8% in other specialties, manufacturer in 78.4% vs 74.2%, and operating room staff in 2.3% vs 16.1%, respectively (p=.007). Injury to patient was similar in gynecologic surgery compared with other specialties (35.1% vs 23.4%, p=.122). Gynecologic and other specialty MEs did not state the need for procedure rescheduling (0% vs 0%). Most reported robotic MEs occurred intraoperatively, were related to robotic instrument malfunctions, and required an instrument switch. Most surgeries are completed robotically, but conversion to either an open or laparoscopic approach was reported in 4.4%. Of the 114 reported injuries, 47.4% were Clavien-Dindo grade III+. There were no differences noted in patient injury between gynecologic surgery and other specialties.

Bent or broken: analysis of set screw fracture in the TFNa implant

ObjectivesTo evaluate set screw fracture in the Trochanteric Femoral Nail Advanced implant (TFNa, Synthes, West Chester, PA) and to identify additional mechanisms of set screw failure in the TFNa.Materials and methodsPatients who had experienced failure after open reduction and internal fixation (ORIF) with the TFNa were identified. TFNa implants were explanted and inspected following revision surgery. Medical device reports (MDRs) and manufacturer’s inspection reports describing similar failures for the TFNa in the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database were also reviewed.ResultsFour set screw fractures that occurred at a level II trauma center were observed. Sixty-seven reported failures were identified in the MAUDE database for review. Twenty-eight failed implants were returned to the manufacturer for inspection with a published inspection report available for analysis. Set screw fractures can occur in the TFNa when the set screw is deployed prematurely into the proximal screw aperture prior to blade/screw insertion. The set screw can also bend and deform if it is advanced against a helical blade/lag screw that is not fully seated into position, thereby potentially compromising its function.ConclusionThe TFNa set screw allows for potential fracture during implant insertion leading to uncontrolled collapse, early excessive proximal femoral shortening, and rotational instability of the helical blade/lag screw. Similar failures in the TFNa can be prevented by having the surgeon inspect the proximal screw aperture after attachment of the proximal aiming aim to ensure the set screw has not been deployed prematurely.Level of evidenceTherapeutic Level III.

Adverse Events Associated With Electromyogram Endotracheal Tubes in Thyroid and Parathyroid Surgery.

Thyroid and parathyroid surgeries are frequently performed with the aid of electromyogram endotracheal tubes. However, the most common adverse events have not been reported comprehensively. This study aimed to summarize the device adverse events, patient complications, and subsequent interventions related to electromyogram endotracheal tubes. In this retrospective cross-sectional analysis, the US Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for electromyogram endotracheal tube adverse events between 2010 and 2020. Data were extracted for devices used in thyroid and parathyroid surgery. Of 198 included reports, the most common device-related adverse events were loss of response to nerve stimulation (34.8%), cuff perforation (18.2%), and tube lumen obstruction (13.6%). Of 98 patient complications, the most common included ventilation failure (n = 50), airway trauma (n = 22), and recurrent laryngeal nerve injury (n = 5). There was 1 periprocedural death reported. Reported interventions include reintubation performed in 60.1% of all device adverse events, extended hospitalization in 27.3% of airway trauma events, and 5 tracheostomies performed for ventilation failure events. Forty-one events resulted in case delays and 13 events led to aborted cases. The most reported adverse events occurred in 2018 (n = 35) and 2015 (n = 30). The most commonly reported adverse events associated with electromyogram endotracheal tubes include loss of response to nerve stimulation, cuff perforation, ventilation failure, and airway trauma. Subsequent interventions include reintubation, tracheostomy, extended hospitalization, and aborted cases. Surgical teams should consider these adverse events when consenting patients and using these devices in thyroid and parathyroid cases.

B-PO03-116 ADVERSE EVENTS RELATED TO ATRICURE EPI-SENSE COAGULATION DEVICE - ANALYSIS OF THE FDA MAUDE DATABASE

The Atricure EPi-Sense Device is used for the hybrid convergent procedure, an emerging treatment for persistent atrial fibrillation (AF) and long standing persistent atrial fibrillation (LSPAF). Except for some mention of adverse events (AE) in the recent CONVERGE IDE trial, not much data is available on the AE related to the EPi-Sense device. To report real world data on the AE related to Atricure Epi-Sense Coagulation Device by interrogating the post-marketing surveillance data from the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. Keyword “EPI-SENSE” was searched on the MAUDE database. There were 80 device reports from 2016-2020. After excluding reports when the device was not returned for evaluation, 79 device reports were included for final analysis. The adverse events were broadly classified into 12 categories as seen in Table 1. The most common complications were pericardial effusion (25.3%), stroke (17.7%) and atrio-esophageal fistula (AEF) (8.9%). Death was reported in 15 (19%) cases, 3 of which were due to pulmonary embolism, 6 due to AEF, 3 due to unknown cause, 1 due to sepsis, 1 due to acute renal failure (ARF) and 1 due to ARF followed by massive pericardial effusion. The major limitation of using the MAUDE database is underreporting, especially the AE occurring due to clinician’s error. Regardless, this analysis of the AE related to the EPi-Sense device highlights several major adverse events that are previously unreported. This further underscores the importance of continued ongoing surveillance of safety profiles, and patient outcomes for the convergent procedure.

Modes of failure with fractional flow reserve guidewires: Insights from the manufacturer and user facility device experience database.

BACKGROUNDFractional flow reserve (FFR) measurement is commonly used in the cardiac catheterization laboratory to assess the functional significance of coronary arterial plaques. Robust real-world data on complications and modes of failure of FFR guidewires are limited. AIMTo characterize these outcomes by analyzing the post-marketing surveillance data from the United States Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database for commonly used FFR guidewires.METHODSThe MAUDE database was queried from January 2010 through April 2020 for 3 FFR guidewires [PressureWireTM X (Abbott), CometTM (Boston Scientific), and VerrataTM (Philips)] by searching for the following events: “Injury”, “malfunction”, “death”, and “other”. This yielded 544 reports. After excluding incomplete reports, 486 reports were analyzed. RESULTSGuidewire tip fracture was the most commonly reported mode of failure, in 174 (35.8%) cases followed by guidewire kinking (n = 152, 31.3%), communication failure (n = 141, 29.0%), and shaft fracture (n = 67, 13.8%). In total, 133 (27.4%) device failures resulted in patient adverse events. The most common adverse event was retained guidewire tip, in 71 (53.4%) cases, followed by freshly deployed stent dislodgment (n = 26, 19.6%) and coronary artery dissection (n = 23, 17.3%). Seven deaths were reported. CONCLUSIONFFR guidewire failures can occur because of various mechanisms and cause patient adverse events. The MAUDE database serves as an important platform for improved collaboration among clinicians, device manufacturers, and regulators to improve device performance and optimize patient outcomes. Our analysis provides mechanistic insights of FFR guidewire failure and associated adverse events but cannot verify causality or provide a comparison among different guidewires.

Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death

In the US, most postmarket medical device safety data are obtained through adverse event reports that are submitted to the US Food and Drug Administration (FDA)'s Manufacturer and User Facility Device Experience (MAUDE) database. Adverse event reports are classified by the reporter as injury, malfunction, death, or other. If the device may have caused or contributed to a death, or if the cause of death is unknown, the FDA requires that the adverse event be reported as a death. To determine the percentage of medical device adverse event reports submitted to the MAUDE database that were not classified as death even though the patient died. In this study, a natural language processing algorithm was applied to the MAUDE database, followed by manual text review, to identify reports in the injury, malfunction, other or missing categories that included at least 1 term that suggested a patient death, such as patient died or patient expired, from December 31, 1991, to April 30, 2020, for any medical device. Manual review of a random sample of 1000 adverse event reports not classified as death and of selected reports for 62 terms that are associated with deaths but were not classified as death. Percentage of adverse event reports in which the patient was said to have died in the narrative section of the report but the reporter classified the report in a category other than death. The terms in the natural language processing algorithm identified 290 141 reports in which a serious injury or death was reported. Of these, 151 145 (52.1%) were classified by the reporter as death and 47.9% were classified as malfunction, injury, other, or missing. For the overall sample, the percentage of reports with deaths that were not classified as deaths was 23% (95% CI, 20%-25%), suggesting that approximately 31 552 reports in our sample had deaths that were classified in other categories. The overall percentage of missed deaths, defined as the percentage of deaths that were classified in other categories, was 17% (95% CI, 16%-19%). Many of the findings of this study suggest that many medical device adverse event reports in the FDA's MAUDE database that involved a patient death are classified in categories other than death. As the FDA only routinely reviews all adverse events that are reported as patient deaths, improving the accuracy of adverse event reporting may enhance patient safety.

Total elbow arthroplasty failures in loosely linked implants: is humeral component aseptic loosening more common than previously thought?

BackgroundDespite improvement in implant design, total elbow arthroplasty (TEA) failures remain a common occurrence with significant patient morbidity. Recent literature points to aseptic loosening as the most common cause of failure. However, investigations of the location of failure are conflicting, and most studies to date have been retrospective reports from single institutions. The aim of this study was to use a national database to investigate the distribution of TEA adverse events according to failure mode and location, with the hypothesis that the aseptic loosening would be the most common cause of TEA failure, and there would be no significant difference between rates of humeral-sided and ulnar-sided failures. MethodsThe US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is a federally mandated reporting system for implant failures. The MAUDE database was searched for TEA adverse event reports among all loosely linked TEA constructs from 2008 to 2019. TEA failure reports were individually analyzed for failure mode and categorized according to anatomic location. The chi-square test was used to statistically assess differences in categorical data between groups. ResultsA total of 869 TEA failure reports were included in this study. The most common mode of failure was aseptic loosening (26.8%) followed by component mechanical failure (23.9%), infection (16.1%), and periprosthetic fracture (11.5%). When evaluating TEA failure reports by anatomic location, the majority of aseptic loosening failures occurred at the humeral component as compared to the ulnar component (71.7% vs. 28.3%; P < .001) whereas there was no difference in rates of periprosthetic fracture according to anatomic location (53.0% humeral vs. 47.0% ulnar; p = .549). ConclusionTEA failure reports in the large and nationally representative FDA MAUDE database differed from what is represented in current literature, with higher rates of humeral component aseptic loosening than has been previously reported. Understanding TEA failure mechanisms will help direct future design and surgical technical improvements. Level of EvidenceLevel IV; Case-series Database Study

A registry review of 2532 catheter ablations for atrial fibrillation using active thermal protection

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Dr Leung has received research support from Attune Medical (Chicago, IL). Dr Gallagher has received research funding from Attune Medical (Chicago, IL). Background Thermal injury to the oesophagus causes a spectrum of adverse effects after ablation for atrial fibrillation (AF); at the most severe end, atrio-oesophageal fistula carries a high mortality rate. Controlled active thermal protection in the oesophagus during ablation is the most promising method of oesophageal protection. Randomized evidence from the IMPACT trial (NCT03819946) showed an 83.4% reduction in endoscopically detected oesophageal lesions compared to standard care when an oesophageal temperature control device was used to control the local temperature. The IMPACT patients who were randomized to the use of the device had no adverse event related to its use. Real world registry data on applications of this device have not previously been available. Purpose To determine the safety of an oesophageal temperature control device by review of real-world registry data on its clinical use and any reported device-related adverse events. Methods We reviewed the following databases for any reported oesophageal temperature control device-related complications: The United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE), FDA Medical and Radiation Emitting Device Recalls, the Medicines and Healthcare products Regulatory Agency (MHRA) Medical Device Alerts and SwissMedic records of Field Safety Corrective Actions (FSCA). An internal registry (post-marketing follow up) database maintained by the manufacturer of the device was used to quantify the number used for each indication. Reported events were reviewed and catalogued for description and identification of any events related to its use in the cardiac electrophysiology lab. The IMPACT study patients were reviewed for any device-related events. Results Of the 13, 284 oesophageal temperature control devices used, 2532 were recorded as having been used for the purpose of oesophageal protection during catheter ablation for AF. A total of 5 events associated with the device were identified, all from the MAUDE database. Three were from 2017, one from 2018, and one from 2019. All involved its use in critical care or trauma patients and were related to user error or contraindicated patient selection; none resulted in serious harm to the patient. No adverse events occurred related to its use in the cardiac electrophysiology lab. No case of clinically significant oesophageal injury was reported in a patient who had been protected by the oesophageal temperature control device. Conclusions Real world registry data has shown no adverse events reported to date in over 2500 uses of an oesophageal temperature control device in the cardiac electrophysiology lab, for the purpose of active thermal protection. This data supports the randomized trial evidence of its clinical effectiveness. Abstract Figure. Oesophageal active thermal protection

Post-Surgical Complications After Bladder Outlet Reducing Surgery: An Analysis of The FDA Manufacturer and User Facility Device Experience (MAUDE) Database

ObjectiveTo examine voluntary reports in the Food & Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, categorize complications and assign device-related causality with transurethral resection of the prostate (TURP), prostatic urethral lift (PUL), and transurethral water vapor therapy (TWVT). MethodsA review was performed using the terms “Urolift,” “Rezum,” and “transurethral resection of the prostate” between 01/01/2015 and 12/31/2019. Duplicate and incomplete reports were excluded. The Gupta system was used to report complications and device related causality.1 Pearson's Chi-square analysis was performed to compare minor (Level 1) versus major (Levels 2-4) complications. ResultsA total of 548 events were examined. After removal of duplicates (n = 60), irrelevant reports (n=65), and incomplete information (n = 14), we included 409 events (74.6%). Of the 409 events, 214 were for TURP, 112 for TWVT, and 83 for PUL. In aggregate, 39.4% of events were minor/Level 1 (n=161/409). The proportion of subjects with Level 2-4 complications versus Level 1 complications was significantly higher for PUL than TURP or TWVT [X2 (2, N = 408) = 41.4023, P < .00001]. Device causality was attributable to device malfunction in 60.4% of cases (n=247/409). ConclusionDevice malfunction was noted in all groups and 39.4% of these were minor (Level 1). However, the majority of PUL reports noted a Level 3 or 4 complication (50.6%, 42/83), primarily bleeding related. Previous studies have not revealed significant risk of bleeding and suggests a discrepancy between study data and real-world experience that may alter patient counseling practices.

Location of Superior Vena Cava Tears in Transvenous Lead Extraction

BackgroundSuperior vena cava (SVC) tears are rare but potentially lethal complications associated with transvenous lead extraction. When lacerations occur, surgeons need to be prepared for an emergent response. Nonetheless, little is known about the precise whereabouts of these lesions. Understanding the location and injury patterns enables a more anticipated and targeted surgical response. MethodsWe collected data via physician interviews after an SVC laceration occurred. These physicians were identified through the US Food and Drug Administration's Manufacturer and User Facility Device Experience database and independent physician reports of adverse events. We identified 116 reports of SVC tears between July 1, 2016, and July 31, 2018. For an SVC tear to be included in our registry, a cardiothoracic surgeon had to be physically present to confirm the injury via emergent sternotomy. In each case, the surgeon recorded the SVC injury's exact location after a repair was attempted. ResultsDuring the study period, 116 SVC tears were confirmed by sternotomy. Tears occurred in any combination of the following locations: SVC–innominate vein, body of the SVC, and SVC–right atrial junction. The majority of tears (n = 72; 62%) were located in the isolated body of the SVC, followed by the SVC–right atrial junction (n = 23;19.8%) and the SVC–innominate junction (n = 17;14.6%). Combined tears were rare, accounting for only 3.6% (n = 4) of the adverse events recorded. ConclusionsMost SVC tears occurred in the isolated body of the SVC. The second most common location was the SVC–right atrial junction. The SVC–innominate junction was the third most common location for these injuries. Combined tears were uncommon.

Adverse Events Associated With Synthetic Male Slings: An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database.

PurposeWe sought to describe and analyze the adverse events associated with synthetic male slings reported to the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.MethodsWe queried the MAUDE database for all entries including the terms “Male Sling,” “InVance,” “Virtue,” or “Advance” from January 1st, 2009 to December 31st, 2018. We collected and analyzed information about the event type, date received, report source, source type, and manufacturer. We reviewed and categorized the event description text for each medical device report (MDR).ResultsA total of 497 adverse events related to the male sling were identified. The adverse events were classified as injury (95.4%), malfunction (4.2%), and other (0.4%). There were no deaths described. The slings involved were the Advance or Advance XP sling (69.8%), InVance (15.5%), Virtue Quadratic (12.3%), or unknown (2.4%). The 4 most common adverse events described were urinary incontinence (46.7%), sling erosion (9.1%), mechanical malfunction (8.2%), and pain/numbness (8.2%). There was no increase in the number of reports in the years following the FDA warnings for urogynecologic mesh.ConclusionsThere was an overall modest number of MDRs related to male slings and the majority of them were reported by the manufacturer. The reporting of adverse events for male slings does not seem to be affected by the controversy and scrutiny towards transvaginal mesh and midurethral slings. Further clinical studies and more objective and detailed databases are needed to investigate the safety of these synthetic slings.