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

Abstract

Background and AimsOver-the-scope clips (OTSCs) 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 have been lacking. The aim of our study was 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. MethodsWe analyzed the FDA MAUDE database post-marketing surveillance data from January 2013 through May 2022 on the two OTSC systems available in the United States. ResultsForty medical device reporting claims were found from January 2013 through May 2022. Adverse events were classified as device-related problems and patient-related adverse events. Forty device-related problems were reported, along with 20 device-related adverse events. 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 system (n = 9). The most common device-related problem was related to the failure of OTSC deployment (n = 13), followed by material protrusion or extrusion (n = 7). The most common patient adverse events were perforation (n = 4), esophageal laceration (n = 4), bleeding (n = 3), and luminal stenosis (n = 3). All 4 patients required surgical management of the perforation. No deaths related to the use of OTSCs were reported. ConclusionFailure of OTSC deployment and perforation were the most common device-related problem and patient-related adverse event, respectively. As the use of OTSC systems continues to increase, it is important for endoscopists to be mindful of both the common and rare adverse events associated with OTSC use.