A comprehensive analysis of reported adverse events with biliary self-expandable metal stents: an FDA MAUDE database study

Abstract

Background and Aims

Endoscopic biliary stent placement is commonly used for multiple indications. This study investigated reported adverse events associated with Boston Scientific WallFlex, Cook Evolution, and Gore Viabil biliary stents.

Methods

The MAUDE (Manufacturer and User Facility Device Experience) database of the U.S. Food and Drug Administration was queried for stent-related reports between March 2013 and April 2023.

Results

Boston Scientific WallFlex stents had 964 device-related events, including 123 patient adverse events, and Cook Evolution stents had 99 device-related events with 21 patient adverse events. Gore Viabil stents exhibited 33 device-related events, including 13 patient adverse events. Of all reported Boston Scientific WallFlex stent cases, 20.3% were infection-related problems, and 25.5% were material/component issues. For Cook Evolution stents, 24% were bleeding/hemorrhage and 33% were breakage as major adverse events. For Gore Viabil stents, 23% were bleeding-related problems, and 36% were structural integrity issues. Comparing fully covered versus uncovered/partially covered Boston Scientific WallFlex stents, the former had more device detachment/migration. Uncovered/partially covered stents had higher rates of activation/positioning/separation issues and device obstruction/blockage.

Conclusions

This study provides insights into the potential adverse events and device failures associated with commonly used biliary stents. Further research is needed to confirm these findings and investigate the underlying causes of these adverse events and device failures.