Advertisement

Patient-Related Adverse Events and Device Failures Associated with Commercially Available Enteral/Duodenal Self-Expanding Metal Stents: An Analysis of the MAUDE Database

Published:October 07, 2022DOI:https://doi.org/10.1016/j.gie.2022.10.008
      This paper is only available as a PDF. To read, Please Download here.

      Background

      Duodenal stents are widely used to treat patients with malignant gastric outlet obstruction, most commonly from pancreatic cancer. The Wallflex and Evolution duodenal stents are in widespread use for treating MGOO. The objective of this study is to analyze the reported device failures and patient-related adverse events reported to the FDA for these two stents.

      Methods

      We analyzed post-marketing surveillance data on the WallFlex Duodenal (Boston Scientific, Natick, MA) and Evolution® Duodenal (Cook Endoscopy, Winston-Salem, NC) stents from Jan 2000 to Jan 2022 through the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database can be accessed at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

      Results

      154 MAUDE reports were identified and analyzed. 176 device failures and 186 patient-related adverse events were identified. Device related failures for the WallFlex stent include delivery system failure (15.4%) and failure to activate the stent (13.2%). Device failures for the Evolution stent include failure to activate the stent (16.5%) and delivery system failure (15.3%). Patient-related adverse events for the Wallflex stent include perforation (18.9%), death (6.6%) and hemorrhage (3.8%). Reports for the evolution stent accounted for 43.0% of analyzed adverse events. Patient-related adverse events for the Evolution Duodenal stent include obstruction (16.3%), perforation (6.3%), aspiration (3.8%), and fragments of broken delivery system left in the patient (3.8%).

      Conclusion

      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.

      Acronyms and Abbreviations:

      MGOO (Malignant Gastric Outlet Obstuction), GJ (Gastrojejunostomy), TTS (Through-the-scope), MAUDE (Manufacturer and User Facility Device Experience), FDA (Food and Drug Administration), ICU (Intensive Care Unit), IRB (Institutional Review Board)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Gastrointestinal Endoscopy
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect