Adverse Events Associated with Absorbable Implants for the Nasal Valve: A Review of the Manufacturer and User Facility Device Experience Database

AbstractThe aim of the study is to report outcomes after treatment of nasal valve collapse with a bioabsorbable nasal implant. It involves two prospective, multicenter, post-market studies evaluating long-term effectiveness of the LATERA implant for severe to extreme nasal obstruction. Participants underwent implant alone or with concomitant inferior turbinate reduction (ITR) and/or septoplasty. Outcome measures included the change from baseline Nasal Obstruction Symptom Evaluation (NOSE) scores, NOSE responder rates, visual analog scale (VAS) scores, and adverse events. A total cohort of 277 participants (109 implants only, 67 implants + ITR, 101 implants + septoplasty + ITR) enrolled at 19 U.S. centers was available for analysis with 177 participants (69 implants only, 39 implants + ITR, 69 implants + septoplasty + ITR) available at 2 years. The mean changes from baseline in NOSE scores and VAS scores were statistically significant (p < 0.001) at all follow-up periods. The baseline NOSE score of 77.8 ± 13.6 was improved to 24.2 ± 23.6 at 24 months. Greater than 90% of participants were NOSE responders across all follow-up periods, 6.1% withdrew for lack of treatment effect. The baseline VAS score of 66.7 ± 18.8 was improved to 21.1 ± 23.9 at 24 months. There were no serious adverse events related to the device or implant procedure. Implant retrieval rate was 4.0% (22/543 implants). Nonserious adverse events were mild to moderate in severity, typically occurred within 6 months of implant, and resolved or were stable. Significant reductions in NOSE and VAS scores and high responder rates from our large population of patients with nasal obstruction who had nasal valve implants confirm sustained effectiveness at 24 months after treatment. The studies are registered on www.clinicaltrials.gov (NCT02952313 and NCT02964312).

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Adverse Events in Total Ankle Arthroplasty, Analysis of the FDA Medical and User Facility Device Experience Database

Foot & Ankle Orthopaedics ◽

10.1177/2473011419s00285 ◽

2019 ◽

Vol 4 (4) ◽

pp. 2473011419S0028

Author(s):

Karim Mahmoud ◽

Sreenivasulu Metikala ◽

Kathryn O’Connor ◽

Daniel Farber

Keyword(s):

Adverse Events ◽

Aseptic Loosening ◽

Mandatory Reporting ◽

Total Ankle Replacement ◽

Total Ankle Arthroplasty ◽

Ankle Arthritis ◽

Ankle Arthroplasty ◽

Ankle Replacement ◽

Mode Of Failure ◽

User Facility

Category: Ankle Arthritis Introduction/Purpose: Total ankle replacement has become a popular treatment option for end stage ankle arthritis. Most of the reports of adverse events following total ankle replacement have been from high volume institutions and are subject to either observational or selection bias as well as potential under-reporting as they do not include the experience of community and lower volume centers and surgeons. The FDA’s Medical and User Facility Device Experience (MAUDE) Database provides a more complete scope of adverse events due to the mandatory reporting requirements by the FDA of implant manufactures. We reviewed the database to identify the common modes of failure and complications of total ankle implants Methods: We retrospectively reviewed reports of the MAUDE database from November 2011 to September 2018 regarding all total ankle implants. Each device in the MAUDE database is classified with a 3-letter code, we identified the 2 codes assigned to total ankle arthroplasty devices, and manually searched the FDA’s published Device Classification list for adverse events. All events were reviewed and classified. Data related to patient age or sex, surgeon, medical center location are not available in the database Results: We identified 1000 adverse reports in the period between November 2011 and September 2018. After exclusion of duplicate reports for single events or reports irrelevant to total ankle arthroplasty, a total of 697 adverse event reports were noted. The most common mode of failure was aseptic loosening (21%), followed by infection (16%), alignment and mechanical issues (instability, malalignment, malposition, stiffness, impingement) (15%), implantation issues (pin, screw or drill breakage, alignment guide problems) (9%), polyethylene related problems (wear, displaced or fractured implants) (7%), bony and soft tissue overgrowth (6%), and peri-prosthetic fractures (5%). Conclusion: Our analysis reveals that the most reported mode of failure was aseptic loosening followed by infection. However, it is notable that there are a significant number of issues with implant alignment and mechanics, complications during implantation and polyethylene component failure that are under-reported in the literature. Knowledge of these adverse events may help surgeons avoid similar complications as well as lead to improvement in component implantation and design

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Abstract 17178: Adverse Events in Endovascular Robotic Assisted Procedures

Circulation ◽

10.1161/circ.138.suppl_1.17178 ◽

2018 ◽

Vol 138 (Suppl_1) ◽

Author(s):

Naveen Kumar Sankaran ◽

Sai Rakesh Rachakonda ◽

Abraham Kocheril ◽

Suraj Kapa ◽

Thenkurussi Kesavadas

Keyword(s):

Adverse Events ◽

Radiation Exposure ◽

Endovascular Procedures ◽

Hemodynamic Instability ◽

Patient Death ◽

User Facility ◽

Robotic Devices ◽

Patient’S Outcome ◽

Aneurysm Repair ◽

The Impact

Introduction: Endovascular procedures are traditionally performed for a variety of indications. However, guidewire/catheter manipulation and hazardous radiation exposure are limitations to manual interventions. Thus, significant work has been done to develop robotic approaches to therapies. These devices have FDA clearance for performing procedures like cardiac arrhythmias, angioplasty, aneurysm repair and stenting etc. With the increasing usage of robotic assistance in endovascular procedures, it is essential to understand the adverse events that may occur. This study aims to provide an understanding of adverse events with currently available robotic systems. Methods: The analysis of adverse events is performed with the FDA MAUDE (Manufacturer and User Facility Device Experience) database. MAUDE database is a collection of reports on medical devices reported by manufacturers, distributors, users, volunteers. In case of occurrence of adverse events, FDA regulations requires that event to be reported for further investigation. Based on the impact of events on the patient’s outcome, the reported events were grouped into 3 categories death (patient death), injury (patient injury) or device malfunction. Results: A total of 71 different events were reported collectively for all the four robotic devices (Hansen Medical- 37, Corindus Inc.-27, Stereotaxis Inc.-5 & Catheter Robotics Inc.-2). The major adverse events included death and common injuries such as perforation, pseudo-aneurysm / blockage/ tamponade/ clot, blood pressure dropped or an effusion, or hemodynamic instability. The table summarizes the events by brand of system. Conclusions: While robotic approaches to intervention reflect a potentially useful means to improve outcomes of endovascular procedures by optimizing catheter manipulation with finer robotic motions or limiting radiation exposure, there are potentially significant risks. Whether these reflect higher or lower risk than traditional manual approaches requires randomized studies. Use of robotic technologies may present additional risks in light of potential malfunctions that occur from system errors that a human system may not be prone to. Future studies will be needed to better understand incremental benefit.

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What is Being Reported About Vaginal “Lasers”?: An Examination of Adverse Events Reported to the Food and Drug Administration on Energy-Based Devices

Aesthetic Surgery Journal ◽

10.1093/asj/sjab299 ◽

2021 ◽

Author(s):

Linda Burkett ◽

Pamela Moalli ◽

Mary Ackenbom

Keyword(s):

Adverse Events ◽

Local Treatment ◽

Safety Data ◽

Co2 Lasers ◽

Laser Technologies ◽

Surgical Devices ◽

Device Type ◽

User Facility ◽

Similar Risk ◽

Sensation Loss

Abstract Background Description of energy-based genitourinary non-surgical devices (energy-based devices) safety data is outlined given their rapid adoption. Objectives To describe adverse events (AEs) for energy-based devices in the Manufacturer and User Facility Device Experience (MAUDE) database, and to compare to similar devices and other subspecialty applications. We hypothesized that products with genitourinary applications had similar AEs to dermatologic or general surgery applications. Methods Reed Tech™ Navigator compiled AE reports for all registered energy-based devices. Individual AE reports associated with 1) non-ablative, 2) fractionated, 3) unfractionated 4) radiofrequency, and 5) hybrid laser technologies were categorized. AE characteristics were compared among genitourinary applications (n=39) and other subspecialty applications within the same devices (n=79). Results Eighteen manufacturers were identified, which collectively manufacture 43 products with genitourinary applications. Thirty-nine genitourinary AEs were reported and isolated to 6 manufacturers with 11 products, of which 82% (n=32) were injuries, 15% (n=6) were device malfunction, and 3% (n=1) related to improper maintenance. Local treatment reactions were the most commonly reported injury (62%, n=21). AEs varied by device type with CO2 lasers having more burns and radiofrequency devices having higher rates of sensation loss. When comparing similar technology types, genitourinary energy-based devices had the least AE reports per device in MAUDE database. Conclusions AEs were reported on a quarter of the products currently available, and most were local treatment reactions. The reporting of AEs is equal to that of other subspecialties suggesting similar risk profiles. Improved reporting is needed to fully evaluate the safety of individual energy-based devices.

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Abstract WP6: Cerebral Mechanical Thrombectomy Device Related Adverse Events: Analysis of the Manufacturer and User Facility Device Experience Database

Stroke ◽

10.1161/str.44.suppl_1.awp6 ◽

2013 ◽

Vol 44 (suppl_1) ◽

Author(s):

Wondwossen G Tekle ◽

Malik M Adil ◽

Derya Uluduz ◽

Basit Rahim ◽

Tauhid Awan ◽

...

Keyword(s):

Adverse Events ◽

Internal Carotid ◽

Reporting Rate ◽

Event Description ◽

Device Malfunction ◽

First Pass ◽

User Facility ◽

Multiple Devices ◽

Thrombectomy Device ◽

Solitaire Fr

Background: There is paucity of knowledge regarding the spectrum of neurothrombectomy(NT) device-related complications. Objective: To report the characteristics and proportions of reported adverse-events(AE) related to NT devices used in endovascular treatment of acute ischemic stroke (AIS). Methods: We identified NT device-related AE reported by voluntary sources, user facility reports, and distributor and manufacturer reports to the Manufacturer and User Facility Device Experience Database(MAUDE) from the year 2004 through 2012 to identify patients. Frequency of specific reported AE and associated factors were extracted from the “event description” on the three NT devices currently in use for AIS treatment -Merci Retriever, Penumbra System, and Solitaire-FR stentriever. Results: A total of 706 reported NT device-related AEs were identified with a continual increase in reporting rate since 2004. Of the 706, device malfunction (kink, twist, difficult advancing, fracture, or retention) was the most common reported complication(56%), followed by hemorrhages(23%), dissection(6.8%), vasospasm(6.2%), and distal embolism(2.7%). Intra-arterial(IA) thrombolytic was used in 70%(111/159), intravenous(IV) thrombolytic in 16%, and both IA and IV in 13% of the reported cases. Middle cerebral artery(MCA) was involved in 56%(220/392), internal carotid artery(ICA) in 16 %, and both MCA and ICA in about 21% of cases where the occluded vessel was reported. Multiple devices were used in majority(71%) of reported cases(n=564). The first “pass”(recanalization-attempt) was associated with 34% of reported adverse event per-device(n= 119), 2-passes(29%), and 3-passes(28%). Recanalization was complete in 52 %(266/513) reported cases, and partial in 14%(71/513). Patients’ condition was unchanged in 63%(220/349), worsened in 29%(101/349), and improved in 8%(28/349) of reported cases. Twenty three percent(77/342) mortality was reported among those patients whose final outcome was known and reported. Conclusions: Reports of NT device-related AE have significantly increased over the last 8 years. Proportionally higher-rates of reported device malfunction do not necessarily represent adverse patient outcomes.

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