Patient-related adverse events and device failures associated with commercially available enteral or duodenal self-expanding metal stents: an analysis of the MAUDE database

Abstract

Duodenal stents are widely used to treat patients with malignant gastric outlet obstruction (MGOO), most commonly from pancreatic cancer. The WallFlex (Boston Scientific, Natick, Mass, USA) and Evolution (Cook Endoscopy, Winston-Salem, NC, USA) duodenal stents are in widespread use for treating MGOO. The objective of this study was to analyze device failures and patient-related adverse events reported to the U.S. Food and Drug Administration (FDA) for these 2 stents. We analyzed postmarketing surveillance data on the WallFlex and Evolution duodenal stents from January 2000 to January 2022 through the FDA's Manufacturer and User Facility Device Experience (MAUDE) database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm). One hundred fifty-four MAUDE reports were identified and analyzed, from which 176 device failures and 186 patient-related adverse events were identified. Device-related failures for the WallFlex stent were delivery system failure (15.4%) and failure to activate the stent (13.2%). Device failures for the Evolution stent were failure to activate the stent (16.5%) and delivery system failure (15.3%). Patient-related adverse events for the WallFlex stent were perforation (18.9%), death (6.6%), and hemorrhage (3.8%), whereas patient-related adverse events for the Evolution duodenal stent were obstruction (16.3%), perforation (6.3%), aspiration (3.8%), and fragments of broken delivery system left in the patient (3.8%). Both stents are associated with device failures such as failure to activate the stent, stent migration, and occlusion by tumor growth. Despite high success rates, duodenal stents can be associated with serious device failures and patient-related adverse events.