S1106 Analysis of Reported Adverse Events Related to Over the Scope Clips: A MAUDE Database Analysis

Abstract

Introduction: Over-the-scope clips (OTSC) have been increasingly used in the management of bleeding, perforations, fistulae, and anastomotic leaks in the gastrointestinal tract. However, since their Food and Drug Administration (FDA) approval in 2010, data on the adverse events of OTSC systems has been lacking. Our study aims to report and analyze adverse events and device failures associated with OTSC systems using the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. Methods: We analyzed the post-marketing surveillance data from the FDA MAUDE database of the two OTSC systems available in the United States: The Padlock clip system and the Ovesco OTSC from April 2017 through May 2022. Results: Thirty-six medical device reporting claims were found from May 2017 through May 2022. Adverse events were classified as device-related problems and patient-related adverse events. Thirty-six device-related problems were reported, along with sixteen device-related adverse events (Table). Most device-related problems were reported in the Padlock defect closure system (n=23), followed by the Padlock pro clip system (n=8) and Ovesco OTSC clip system (n=5). The most common device-related problem was related to the failure of deployment of OTSC (n=14), followed by material protrusion or extrusion (n=6). The most common patient adverse events were perforation (n=4), bleeding (n=3), esophageal laceration (n=3) and luminal stenosis (n=2). Three out of four perforations were in the Padlock pro select closure system. All four patients required surgical management of the perforation. No deaths related to the use of OTSC were reported. Conclusion: Using the data from a publicly available database, the overall adverse events from OTSC systems remain low. Failure of OTSC deployment and perforation were the most common device-related problem and patient-related adverse events, respectively. The identification of common adverse events has the potential to optimize device design and patient outcomes. It is important for endoscopists to be mindful of these potential adverse events when using over-the-scope clips. Table 1. - Device-related problems and adverse events Device-related problems Number Failure of OTSC deployment 14 Other 8 Separation problems 3 Detachment of the device 2 Protrusion or extrusion of over the scope clip system 6 Defective device component 2 Failure of positioning of the device 1 Total 36 Patient related- adverse events Number Gastro-gastric fistula 1 Perforation 4 Local trauma 1 Pain 1 Bleeding 3 Pyloric stenosis 1 Colonic stenosis 1 Esophageal laceration 3 Ulcer 1 Total 16