A Comparison of Patient and Device Issues Reported for Recalled Venous Stent Systems

Abstract

The first two Food and Drug Administration (FDA)-approved stents for treatment of iliofemoral vein obstruction, Boston Scientific's Vici and BD's Venovo venous stent systems, were both recalled in early 2021 within years of entering the market. Given the recent addition of patient issues as a publicly reported variable by the FDA Manufacturer and User Facility Device Experience (MAUDE) database, we set forth to analyze adverse event reports in MAUDE to better characterize issues reported for each system. MAUDE was queried for all adverse event reports for brands "Vici" and "Venovo" from their respective US FDA market approval dates to August 19, 2021. Reported device issues, patient issues, and interventions performed for each adverse event were compiled and compared using Fisher's exact test. A total of 50 unique adverse event reports were compiled for the Vici system and 341 for the Venovo system. The most common device issue reported for the Vici system was migration (48% vs. 0%; P=0.0001) versus activation failure in Venovo (85% vs. 4%; P=0.0001). A significantly higher proportion of Venovo reports specified no patient complications or symptoms (90% vs. 26%; P=0.0001), with no intervention performed (89% vs. 32%; P=0.001). A significantly higher proportion of Vici devices were extracted (8% vs. 2%; P=0.01), required use of a new device (26% vs. 5%; P=0.0001), and required application of a second stent within the venous stent initially placed (28% vs. 2%; P=0.0001). The rate of intervention with balloon expansion was not significantly different between the Vici and Venovo systems (6% vs. 2%; P=0.08). While 2 venous stent systems were recalled simultaneously, significant differences exist between reported device issues in MAUDE and whether patient injury was involved and well described. Our data suggest that despite recent improvements to MAUDE reporting, additional standardization with specificity regarding patient issues and interventions is needed to assist vascular surgeons monitoring real-time adverse event trends for vascular devices.