Device Complications and Outcomes Before and After FDA Recall of the VICI and Venovo Venous Stent Systems

Abstract

The first two Food and Drug Administration (FDA) approved stents specific for iliofemoral vein obstruction, the VICI (Boston Scientific, Marlborough, MA) and Venovo (Becton, Dickinson and Co, Franklin Lakes, NJ) venous stent systems, were recalled on April 12, 2021 and May 12, 2021, respectively, within years of entering the market. We analyzed the publicly reported adverse events in the FDA Manufacturer and User Facility Device Experience (MAUDE) database to better characterize the predominant device and patient issues reported for each system over their recall timelines.