User Facility Device Experience Database Research Articles

Failure to treat ventricular tachycardia or ventricular fibrillation by implantable cardioverter-defibrillators

BackgroundNormally functioning implantable cardioverter-defibrillators (ICDs) with intact lead systems occasionally fail to deliver therapy for ventricular tachycardia/fibrillation (VT/VF) or deliver it only after clinically significant delays (failure-to-treat). ObjectiveWe aimed to investigate ICD failure-to-treat VT/VF in a large patient cohort. MethodsWe searched the US Food and Drug Administration's online Manufacturer and User Facility Device Experience (MAUDE) database from 2019 to 2023 for manufacturer-verified reports in which normally functioning ICDs failed to treat VT/VF. ResultsWe identified 854 reports classified as deaths (n = 96 [11.2%]), injuries (n = 585 [68.5%]), or malfunctions (n = 173 [20.4%]) for normally functioning ICDs. The most common causes were misclassification as supraventricular tachycardia (SVT) or atrial fibrillation (AF; 54.8%), undersensing (21.1%), and failure to satisfy programmed rate/duration criteria (8.7%). Most events caused by misclassification as SVT/AF (89.5%) and failure to satisfy rate/duration criteria (70.3%) were VT; most caused by undersensing were either VF (54.4%) or not specified as VT or VF (19.4%). Undersensing caused 65.6% of deaths, although it represented only 21.1% of reports. In the United States, the number of reports increased faster than that of ICD patients. ConclusionIn the largest reported series of failure-to-treat VT/VF by normally functioning ICDs, the most common cause was misclassification of VT as SVT/AF; the most common cause of death was undersensing of VF. Although relatively few patients with normally functioning ICDs experience failure-to-treat VT/VF, the absolute number of verified MAUDE reports suggests that more work is needed to quantify the magnitude of the problem, to identify root causes, and to develop solutions.

Adverse events related to suction electrocautery devices in adenotonsillectomy: Analysis of the MAUDE database

ObjectiveTo identify adverse events (AEs) related to suction electrocautery use during adenotonsillectomy. MethodsThe US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was searched using the terms “suction cautery,” “suction electrocautery,” “suction Bovie,” and “suction coagulator” from January 2014 to December 2023. Results165 AE reports were gathered from the MAUDE database medical device reports (MDRs). 36 met inclusion criteria. Patient injuries were found in 22 (61.1 %) reports and device malfunction events were found in 14 (38.9 %) reports. All patient injuries were thermal burns (N = 22, 100 %). Location of burn injuries included the lip (N = 6, 27.3 %), oral commissure (N = 5, 22.7 %), and tongue (N = 4, 18.2 %). The most common cause of an AE was inadequate device insulation (N = 7, 19.4 %). ConclusionThe suction electrocautery apparatus may malfunction and cause patient burn injuries. Device failures mainly result from inadequate device insulation, coagulation problems, and detachment of device components. Surgeons must be aware of these potential complications and counsel parents and patients regarding AEs.

Complications Associated with AMBU™ Scope Use: An FDA MAUDE Analysis.

Ambu® aScope™ is a disposable flexible videoscope used for a wide range of medical procedures. However, adverse events associated with this device can occur. The Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was explored for patient-related adverse events associated with Ambu® aScope™ use between January 1, 2000 and December 15, 2023. Search terms included "Ambu" and "Ascope." Thirty unique adverse events were identified. Twenty-one of the events were associated with patient injury, and 9 with device malfunction. Eight patient-reported problems were documented as foreign bodies, 3 events as airway obstruction, desaturation, or hypoxic events, and 1 event as anxiety/cardiac arrest. The remaining 18 reported insufficient information other than associated with patient injury. We found that Ambu® aScope™ flexible nasolaryngoscopes and bronchoscopes are a common and effective tool for airway evaluations that may infrequently serve as a rare form of foreign body with potentially life-threatening consequences.

Comprehensive Analysis of Adverse Events Associated With Hypoglossal Nerve Stimulators: Insights From the MAUDE Database

AbstractObjectiveThis study aims to examine the adverse events associated with hypoglossal nerve stimulator (HNS) implantation for treating obstructive sleep apnea (OSA), drawing data from the Manufacturer and User Facility Device Experience (MAUDE) database. We aim to provide a comprehensive and updated account of these adverse events.Study DesignRetrospective analysis.SettingMAUDE Database review.MethodsA retrospective analysis was performed on the MAUDE database to collect all HNS‐related reports from May 2014 to December 2023. Variables collected included date of event, event description, nature of event, iatrogenic injuries, required interventions, and, if available, root causes. Each event description was analyzed to classify the adverse event, the postevent intervention, and device model number.ResultsOut of 1178 reports fulfilling the inclusion criteria, 1312 adverse events were identified. Common adverse events included infection (24.0%), pain (19.7%), and hematoma/seroma (10.2%). Approximately 83.1% of these adverse events necessitated medical and/or surgical intervention. The most frequent procedures included explantation (29.4%) and device repositioning (15.8%). Pneumothorax was reported in 50 cases, with 41 (82.0%) requiring a chest tube to be inserted. Three adverse events described overstimulation in the setting of magnetic resonance imaging (MRI) despite the implantation of MRI‐compatible second‐generation internal pulse generators.ConclusionWhile HNS implantation has been established as a reliable intervention for OSA in cases of continuous positive airway pressure failure or intolerance, this study highlights several perioperative and postoperative difficulties and complications. Understanding these challenges is essential for refining surgical practices and enhancing patient consent processes, ultimately aiming to improve therapeutic outcomes.

Are There Hidden Adverse Events in Hypoglossal Nerve Stimulation: Comparing Social Media and a Federal Database.

Hypoglossal nerve stimulation (HNS) can be an effective treatment for moderate to severe obstructive sleep apnea (OSA) in positive airway pressure (PAP) intolerant patients. To better understand patient experiences with HNS therapy, we explored reported events from HNS-related Facebook groups and the Manufacturer and User Facility Device Experience (MAUDE) database. A retrospective analysis of HNS-related Facebook posts from three groups pertaining to HNS therapy, from October 1, 2022 to October 1, 2023, was performed. Posts were analyzed for patient-reported adverse events. Concurrently, the MAUDE database was reviewed for HNS-related events during the same timeframe. From 737 Facebook posts, 132 (17.55%) adverse events were identified. Adverse events included pain (34.85%), stimulation discomfort (14.39%), lip weakness (6.82%) and issues related to lead tethering or tight leads around the neck (3.79%). Analysis of the MAUDE database found 428 adverse events, including pain (24.07%), lip weakness (0.44%), and lead tethering (1.64%). Facebook group members reported higher rates of lip weakness and lead tethering than recorded in the MAUDE database. These findings illustrate how diverse data sources, such as social media, can enhance our understanding of patient experiences and identify gaps in patient education with HNS therapy. NA Laryngoscope, 2024.

Reasons for Revision Surgery After Cervical Disk Arthroplasty Based on Medical Device Reports Maintained by the US Food and Drug Administration.

Retrospective database review. The aim of this study was to analyze revisions of CDAs reported to the MAUDE database. Cervical disk arthroplasty (CDA) has emerged as a motion-preserving alternative to anterior cervical discectomy and fusion (ACDF) for degenerative cervical disease, demonstrating comparable outcomes. Despite the availability of variable CDA designs, there is limited data on the specific complications of individual CDAs. The Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database has been used to systematically report complications associated with CDAs. However, data on specific reasons for CDA revision remains scarce. The purpose of this study is to compare common complications associated with revision for different CDAs. The MAUDE database was queried from January 2005 to September 2023, including all nine FDA-approved CDAs. The full-text reports of each complication were categorized based on whether revision surgery was performed, the complications and the type of CDA collected and compared. A total of 678 revisions for nine CDAs were reported: Mobi-C (239), M6 (167), Prodisc-C (88), Prestige (60), PCM (44), Bryan (35), Secure (23), Simplify (21), and Discover (1). The top three complications associated with revision were migration (23.5%), neck pain (15.5%), and heterotopic ossification (6.6%). The most common complications per device were migration for Mobi-C (26.4%), Prodisc-C (21.3%), Prestige (24.6%), PCM (84.1%), Bryan (48.6%), Secure (30.4%), and Discover (100%). For M6, the most common complications associated with revision surgery were osteolysis (18.6%) and neck pain (18.6%), while neck pain (23.8%) was the most common for the Simplify. The MAUDE database highlights complications related to CDA revision in which the primary complications consistently include implant migration, neck pain, and heterotopic ossification, varying in their rerelvance depending on the CDA. Level II.

Characterizing the safety profile of vagus nerve stimulation devices for epilepsy from 21,448 manufacturer and user reports.

This study summarizes medical device reports (MDRs) associated with adverse events for vagus nerve stimulation (VNS) devices indicated for epilepsy as reported by the Manufacturer and User Facility Device Experience (MAUDE) database of the US Food and Drug Administration. The MAUDE database was surveyed for MDRs from November 2013 to September 2022 regarding VNS devices for epilepsy. Event descriptions, device problems, correlated patient consequences, and device models were grouped and analyzed in Python. Based on event description, revision surgeries and other unique events were identified. Revenue from VNS device sales was used to approximate growth in their use over time. A total of 21,448 MDRs met the inclusion criteria. High VNS impedance, the most prevalent device malfunction overall (17.0% of MDRs), was the most common factor for 18 of the 102 encountered patient problems and led to 1001 revision surgeries (3371 total revisions). Included in those 18 device malfunctions were 3 of the top 6 occurring patient problems: seizure recurrence (9.9% associated with high impedance; encompassed focal, absence, and grand mal subtypes), death (1.3%), and generalized pain (7.9%). The next 4 top cited device malfunctions-lead fracture (13.7% of MDRs), operational issue (6.6%), battery problem holding charge (4.2%), and premature end-of-life indicator (2.9%)-differed widely in their percentage of cases that did not impact patients (77.4%, 57.3%, 48.9%, and 92.2%, respectively), highlighting differing malfunction severities. Seizure recurrence, the most prevalent patient impact, was the outcome most associated with 32 of the 68 encountered device problems, including high impedance (12.8%), lead fracture (12.2%), operational issue (18.4%), battery problem holding charge (31.2%), and premature end-of-life indicator (8.9%), which comprised the top 5 occurring device problems. In general, MDRs spanned a diverse range including device age, hardware, software, and surgeon or manufacturer error. Trends were seen over time with declining annual MDRs coupled with a rise in the use of VNS devices as gauged by revenue growth. Shifting device and patient problem profiles were also seen in successive models, reflecting engineering updates. This study characterizes the most common and consequential side effects of VNS devices for epilepsy while clarifying likely causes. In addition, the outcomes of 68 distinct device malfunctions were identified, including many not ubiquitously present in literature, lending critical perspective to clinical practice.

A Comprehensive Analysis of Reported Adverse Events and Device Failures Associated with Esophageal Self-Expandable Metal Stents: An FDA MAUDE Database Study.

Esophageal Stents are used to maintain esophageal lumen patency in esophageal strictures caused by intrinsic and/or extrinsic malignancies and the occlusion of concomitant esophageal fistulas. While data on the efficacy and safety of esophageal stents exist, comprehensive evaluation of adverse events is limited. The aim of this study is to investigate the reported adverse events and device failures associated with esophageal self-expandable metal stents (SEMS) using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. Post-marketing surveillance data for the esophageal SEMSs were analyzed using the FDA's MAUDE database from January 2014 to December 10, 2023. The outcomes of interest were patient-related adverse events and device failures. Statistical analysis was performed using Microsoft Excel 2010 and SPSS. Pooled numbers and percentages were calculated for each adverse event. Continuous variables underwent analysis using a two-tailed student t test, and significance was set to p ≤ 0.05. During the study period, 548 MAUDE reports revealed 873 device failures and 186 patient-related adverse events. The most common device issues were stent activation, positioning, or separation problems (4 n = 403; 46.2%), followed by device detachment or migration (n = 109, 12.5%), and material problems (n = 93, 10.7%). Patient complications included dysphagia/odynophagia (10%), perforation, pain, and bleeding (each 7.6%). The most common device failures in over-the-wire (OTW) stents and through-the-scope (TTS) stents were activation, positioning, or separation problems (TTS: n = 183, 52.6% vs OTW: n = 220, 41.9%). Compared to OTW stents, TTS stents had higher migration and breakage (13.5% vs. 11.8%, p = 0.24), and (9.2% vs. 6.7%, p = 0.08) respectively, while OTW stents had more challenges with stent advancement or removal (5.1% vs. 0.3%, p < 0.001 and 4.6% vs 3.4%, p = 0.19, respectively) and material problems (14.7% vs. 4.6%, p < 0.001). Activation, positioning, and separation problems were the most frequent device failures in fully covered (FC) and partially covered (PC) stents (FC: n = 62, 32.8%, PC: n = 168, 43.5%). FC stents had higher migration rates (20.6% vs 9.8%, p < 0.001), while PC stents exhibited more material problems (17.4% vs. 5.8%, p < 0.001) and difficulties with advancing the stents (6.7% vs. 0%, p < 0.001). Our examination showed a prevalence of reported device complications associated with stent activation, positioning, and separation problems. Dysphagia or odynophagia emerged as the most frequently reported patient complication. Furthermore, our analysis, provides insights into TTS vs. OTW and FC vs. PC esophageal SEMSs, enabling endoscopists and manufacturers to better understand adverse events and potentially optimize device design for future iterations.

Auditory brainstem implants: an analysis of adverse events in the MAUDE database

ObjectiveAuditory Brainstem Implants (ABI) are used to restore hearing in patients lacking appropriate cochlear anatomy and/or cochlear nerve. The objective of this study was to examine the Manufacture and User Facility Device Experience (MAUDE) database to analyze adverse events. Study designThis is a study of a multi-institutional database maintained by the US FDA. SettingA database analysis was performed via collaboration of multiple clinicians at tertiary referral centers. MethodsThe MAUDE database was queried for Medical Device Reports (MDRs) relating to ABIs. MDRs were identified using the advanced search term “Implant, Auditory Brainstem” and reviewing all reports with the basic search term “Brainstem Implant”. All collected reports were individually reviewed. ResultsA total of 265 individual patient reports were reviewed, of which 55 reports met inclusion criteria. Reports regarding audiologic outcome included failure to provide hearing benefit (n = 27), implant failure/device malfunction (n = 10), and device non-use (n = 6). Postoperative complications included local skin infection (n = 3), CSF leak (n = 3), elevated ICP (n = 1), surgical site dehiscence (n = 1), swelling (n = 1), seroma formation requiring drainage (n = 1), and meningitis (n = 2). Two patients had dislodged magnets during 1.5 Tesla MRI acquisition. There were 35 instances of full explantation of the device and 1 partial removal; 13 patients had a new device implanted following explantation. ConclusionsPoor hearing results, device failure, and non-use were commonly reported causes for explanation in this analysis. This information can aid physicians in counseling patients and family members and managing device expectations.

Major Clinical Adverse Events of Breast Implant in the Manufacturer and User Facility Device Experience Database.

Search the Manufacturer and User Facility Device Experience database to collect information on adverse events of breast implant. We analyzed the local complications and the breast implant illness (BII) of silicone breast implants, as well as saline breast implants separately, aim to provide a reference for women who want to breast augmentation. The Manufacturer and User Facility Device Experience database was queried for events reports related to the breast implant between July 1, 2012, and June 30, 2022. Event year and reporting year were summarized. Patient problem was collected and analyzed to distinguish between local complications and BII. A total of 108,728 adverse events in the past 3 years were analyzed, silicone breast implants accounted for 62.1% and saline breast implants accounted for 37.9%. The most common local complication of women receiving silicone breast implants was "Capsular Contracture," accounting for 48.73%. However, the incidence of "capsular contracture" in women who received saline breast implants was only 17.49%. The most common BII was "fatigue/weakness" in both women receiving 2 different breast implants, 17.20% in women receiving silicone breast implants and 24.71% in women receiving saline breast implants. Of note, in all the reports, there was a wide variation in the timing of reporting as compared with the timing of the adverse event. Although the adverse events of breast implant cannot completely be determined from this study, we provide a reference for women who want to get breast implants, so that they can choose breast implants more carefully. In addition, a better understanding of BII may allow them to think further about whether the benefits of breast implants outweigh the risks.

Infections Associated with Medtronic Duet External Ventricular Drains - Rhode Island Hospital, Providence, Rhode Island, January 2023-January 2024.

External ventricular drains (EVDs) are medical devices that are inserted into the ventricles of the brain to drain excess fluid, manage intracranial hypertension, monitor intracranial pressure, and administer medications. Unintentional disconnections and breaks or fractures (breaks) of EVDs or associated drainage system components can result in cerebrospinal fluid (CSF) leakage and increased risk for EVD-associated infections. After replacement of Integra Life Sciences EVD systems with Medtronic Duet EVD systems at Rhode Island Hospital in mid-September 2023, a threefold increase was observed in the prevalence of positive CSF cultures, from 2.8 per 1,000 days with an EVD in place (EVD days) during January-September 2023 to 11.4 per 1,000 EVD days during October 2023-January 2024 (rate ratio [RR] = 5.7; 95% CI = 1.5-22.0; p = 0.01) and an eightfold increase in the prevalence of infections, from 0.7 to 6.5 per 1,000 EVD days (RR = 9.8; 95% CI = 1.1-87.3; p = 0.04). An investigation by Rhode Island Hospital Infection Control during December 2023-January 2024 identified frequent reports of disconnections and breaks of the Medtronic Duet EVD system. A search of the Food and Drug Administration Manufacturer and User Facility Device Experience database identified 326 reports nationwide of disconnection and breaks of components of the Duet EVD system, including 175 during 2023. A Medical Product Safety Network report was filed. The Duet EVD product was ultimately recalled in January 2024, citing disconnections of the EVD system and reports of CSF leakage and infection. Given the widespread use of EVD systems by neurosurgery centers and the risk for EVD-associated infections, a strategy for future consideration by hospital infection prevention and control programs might be inclusion of EVD-associated infections in hospital surveillance programs to rapidly identify increases in these events and determine factors related to such infections to prevent additional infections.

Analysis of Reported Adverse Events Related to Hemospray: An FDA MAUDE Database Study.

Topical hemostatic powder is a mineral powder that forms an adherent barrier and coagulates active bleeding in the gastrointestinal (GI) tract. Hemospray is the first hemostatic powder approved by the Food and Drug Administration (FDA) in the United States. Hemospray has been increasingly used to manage GI bleeding. However, data on the adverse events of hemostatic powders are lacking. Therefore, we aim to report and analyze adverse events associated with Hemospray using the FDA's "Manufacturer and User Facility Device Experience" database. We analyzed the postmarketing surveillance data from the FDA's Manufacturer and User Facility Device Experience database for Hemospray, initially known as TC-325, from June 2018 through April 2022. Results of the search were classified into device-related technical issues, patient-related adverse events and health care staff-related adverse events. Five hundred two medical device reporting claims were identified from June 2018 through April 2022. Seven duplicate claims were identified, and some claims included more than one event type. Therefore, there were 558 device-related problems, 28 patient-related adverse events, and 2 adverse events in health care staff members. The most common device-related problems were activation failure or failure to fire (n = 385, 70.0%) and obstruction of carbon dioxide flow (n = 121, 21.7). The most common patient-related adverse events included tissue injury or bleeding (n = 21) and perforation (n = 5). Although Hemospray is a valuable tool in the armamentarium for endoscopists in managing GI bleeding, endoscopists must be mindful of deice-related problems and potential patient-related adverse events.

Adverse events associated with Vibrant Soundbridge: A MAUDE study

ObjectiveTo summarize adverse events and their root causes reported to the United States Food and Drug Administration (FDA) on Vibrant Soundbridge (VSB) hearing device (Med-El, Innsbruck, Austria), an active middle ear implant for patients with moderate to severe hearing loss. Materials and methodsThe FDA's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of VSB adverse events from January 1, 2012, to July 27, 2022. ResultsSix hundred sixty-three total medical device reports were identified, from which 913 adverse events were extracted. Of these, 498 (54.5 %) were adverse events to patients (AEPs), while 415 (45.5 %) were device malfunctions (DMs). The most common AEPs were hearing performance issues 428 (85.9 %). The most common DMs were compromised conductive link 125 (30.1 %). Root causes identified for DMs were iatrogenic 85 (58.6 %), patient-related 28 (19.3 %), and trauma and external causes 32 (22.1 %). The most common iatrogenic root cause 12 (14.1 %) involved damage to the conductive link during revision surgery. The most common patient-related causes of DMs were excessive middle ear tissue growth 16 (57 %), and abrupt body movements 5 (28.6 %). The most common external cause of DM was cleaning of the ear canal or mastoid cavity 20 (62.5 %). ConclusionsDespite its well-known limitations, the MAUDE database provides valuable information on possible complications of VSB as it relates to device malfunction or adverse events for patients. Implementation of standardized reports with relevant and well-defined categories could certainly allow for a more meaningful analysis.

Are adverse events during surgery for benign prostatic hyperplasia device related? A review of the MAUDE database.

The Manufacturer and User Facility Device Experience database contains anonymous, voluntary medical device reports. A review of device-related adverse events associated with Benign Prostatic Hyperplasia surgeries was completed. The objective was to evaluate the occurrence and contributing factors to clinically significant complications in a cohort of patients electing to undergo surgical intervention for Benign Prostatic Hyperplasia. The Manufacturer and User Facility Device Experience database was queried for "Aquablation, Greenlight Laser, Holmium Laser, Morcellator, Water Vapor Thermal Therapy, Loop Resection, and Prostatic Urethral Lift" from 2018 through 2021. A complication classification system (Level I-IV) based on the Clavien-Dindo system was used to categorize events. These events were then correlated with procedural technology malfunctions and classified as "device related" and "non-device related." Chi squared analysis was performed to identify associations between procedural technology and complication classification distribution. A total of 873 adverse events were identified. The adverse events were classified into level I (minimal harm) versus levels II-IV (clinically significant). Aquablation (p < 0.017) and Water Vapor Thermal Therapy (p < 0.012) were associated with a higher proportion of reports with Level II-IV complications compared with other procedure types. Level II-IV complications were not associated with a reported device related malfunction. Aquablation and water vapor thermal therapy demonstrated noteworthy clinically significant complications which were not driven by device-related malfunctions.

Adverse events associated with anastomotic coupling devices in microvascular reconstruction

ObjectiveIn light of the recent US Food and Drug Administration (FDA) Class 2 safety recall notice for anastomotic coupling devices, it is important to understand related adverse events. The aim of this study was to characterize adverse events in anastomotic coupling devices for microvascular reconstruction. MethodsA retrospective cross-sectional analysis using the 2011 to 2021 US FDA Manufacturer and User Facility Device Experience (MAUDE) database. All reports of adverse events involving anastomotic coupling devices were retrieved from the MAUDE database. Descriptive statistics were used to analyze categorized events. ResultsThere were a total of 293 documented adverse events related to anastomotic coupling devices. These adverse events resulted in 91 (31.1 %) patient injuries and 239 (81.6 %) device malfunctions. The most frequent patient problems were thrombosis/hematoma (n = 38; 41.8 %), unspecified injury (n = 31; 34.1 %), and failure to anastomose (n = 13; 14.3 %). Free flap necrosis was reported in 42 % of thrombosis/hematoma cases (n = 16). The most common malfunctions were devices operating differently than expected (n = 74; 31.0 %), connection problems (n = 41; 17.2 %), and twisted/bent material (n = 19; 7.9 %). There was no significant trend in the number of adverse events over the study period (p > 0.05). ConclusionsAdverse events from anastomotic coupling devices represent an important and modifiable factor in free tissue failure. Adverse events are predominately related to devices operating differently than expected and may result in vascular compromise of the free flap. Reconstructive surgeons should be cognizant of defective anastomotic coupling devices and be prepared to utilize traditional hand-sewn anastomosis.

Major Complications and Adverse Events Related to Use of SpaceOAR Hydrogel for Prostate Cancer Radiotherapy

ObjectiveTo determine the prevalence and severity of SpaceOARTM-related adverse events using the Manufacturer and User Facility Device Experience (MAUDE) database. MethodsWe analyzed SpaceOAR-related adverse event reports in the Manufacturer and User Facility Device Experience (MAUDE) database from January 2015 to May 2023. For each report, the event type, associated device and patient problems, event description, event timing, and event severity stratified by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE) grading system were recorded. ResultsFrom 2015 to 2022, 206,619 SpaceOAR devices were sold. From January 2015 to May 2023, we identified 981 reports describing 990 SpaceOAR-related adverse events. Malfunctions were the most common event type (N=626), followed by patient injuries (N=350) with few reported deaths (N=5). Device positioning problems were the most frequent device issue (N=686). Pain was the most reported patient problem (N=216). Abscesses and fistulas related to the device were each reported in 91 events. A noteworthy portion of relevant adverse events occurred before the initiation of radiation (N=35, 22.4%), suggesting the device, rather than the radiation, was responsible. In total, 470 (50.2%) and 344 (36.7%) of the adverse events were CTCAE grade 1 and 2, respectively. There were 123 (13.1%) events that were CTCAE grade ≥ 3. ConclusionWe identified multiple reports of SpaceOAR-related adverse events, many of which are more serious than have been reported in clinical trials. While SpaceOAR use is common, suggesting these events are rare, these data highlight the need for continued postmarket surveillance.

(215) Penuma® Penile Implant Adverse Events in the Manufacturer and User Facility Device Experience (MAUDE) Database

Abstract Introduction Penuma® is an FDA-approved penile implant intended to increase flaccid penile length and girth for improved cosmesis. It is the only FDA-approved product of its kind, with reportedly thousands of implants since 2004. There is a paucity of data on the adverse events related to this procedure. Objective To describe and characterize adverse events related to Penuma® using a national database. Methods The Manufacturer and User Facility Device Experience (MAUDE) database, a voluntary-reported database of medical device complications with data since 1991, was queried. The MAUDE adverse event classification system, a validated classification system, was used as a standardized tool to classify adverse events based on severity. All adverse events related to Penuma® were identified and quantified. Results 42 reports of adverse events related to Penuma® were identified (Figure 1). Of these, 35 patients were reported to undergo device removal most commonly due to infection (n=8) or protrusion (n=8). (Table 1). The most commonly reported adverse event was deformity/disfigurement (n=27), of which 18 cases reported loss of penile length. Other adverse events included: pain (n=16), infection (n=12), decreased sensitivity (n=10), scar tissue (n=9), erectile dysfunction (n=8), seroma (n=7), and erosion (n=6). Conclusions To our knowledge, this is the first study to systematically characterize publicly reported adverse events occurring with Penuma® implantation, using the MAUDE database. Further research is warranted to delineate the incidence of adverse events related to Penuma®. Disclosure No.

Adverse events of the single-operator cholangioscopy system: a Manufacturer and User Facility Device Experience database analysis

SpyGlass single operator cholangioscopy (SOC) system is generally considered safe but adds additional risks to those associated with standard endoscopic retrograde cholangiopancreatography. We evaluated adverse events (AEs) with the SpyGlass System reported in the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between January 2016 & August 2023. A total of 2331 device problems (SpyGlass DS:1301, SpyGlass DS II:1010) were reported. An optical problem was the most reported issue with 83 for the SpyGlass DS and 457 for the SpyGlass DS II. Patient related events were found in 62 (3.5%) of 1743 reports: 33 with SpyGlass DS, and 29 with SpyGlass DSII. The most common AEs were bleeding/hemorrhage followed by perforation, infection, fever, or sepsis and pancreatitis. Our findings add to the existing literature and provides a fuller picture of potential problems associated with SpyGlass™ SOC.

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.