Analysis of Publicly Reported Adverse Events In The Vici And Venovo Venous Stent Systems

INTRODUCTION AND OBJECTIVES The first two FDA approved stents for treatment of iliofemoral vein obstruction, Boston Scientific's VICI and BD's Venovo Venous Stent Systems, were both recalled early 2021, within years of entering market. We set forth to analyze publicly reported adverse events in the FDA Manufacturer and User Facility Device Experience (MAUDE) database to better characterize predominant device and patient issues reported for each system. METHODS 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, device return status, and intervention performed for each adverse event were compiled and compared utilizing Fisher's exact test. RESULTS A total of 50 adverse event reports were compiled for the VICI system and 341 for the Venovo system. The most common device issue reported was migration in VICI (48% vs 0%; p=0.0001) versus activation failure in Venovo (85% vs 4%; p=0.0001). A higher proportion of Venovo adverse event reports specified no patient complications or symptoms (90% vs 26%; p=0.0001) and device return to manufacturer (13% vs 2%, p=0.07). There were several significant differences between interventions reported following adverse events for each respective device (Table) CONCLUSIONS While two venous stent systems were recalled simultaneously, significant differences exist between reported device issues in MAUDE and whether patient injury was involved. Our data suggests that despite recent addition of patient issues to MAUDE reporting, standardized inclusion of reporting specific interventions would greatly assist vascular surgeons monitoring real-time adverse event trends for vascular devices. The first two FDA approved stents for treatment of iliofemoral vein obstruction, Boston Scientific's VICI and BD's Venovo Venous Stent Systems, were both recalled early 2021, within years of entering market. We set forth to analyze publicly reported adverse events in the FDA Manufacturer and User Facility Device Experience (MAUDE) database to better characterize predominant device and patient 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, device return status, and intervention performed for each adverse event were compiled and compared utilizing Fisher's exact test. A total of 50 adverse event reports were compiled for the VICI system and 341 for the Venovo system. The most common device issue reported was migration in VICI (48% vs 0%; p=0.0001) versus activation failure in Venovo (85% vs 4%; p=0.0001). A higher proportion of Venovo adverse event reports specified no patient complications or symptoms (90% vs 26%; p=0.0001) and device return to manufacturer (13% vs 2%, p=0.07). There were several significant differences between interventions reported following adverse events for each respective device (Table) While two venous stent systems were recalled simultaneously, significant differences exist between reported device issues in MAUDE and whether patient injury was involved. Our data suggests that despite recent addition of patient issues to MAUDE reporting, standardized inclusion of reporting specific interventions would greatly assist vascular surgeons monitoring real-time adverse event trends for vascular devices.