Indication-Specific Adverse Events and Temporal Trends of Lumen-Apposing Metal Stents: A National Postmarketing Surveillance Analysis (2020–2025)

Background and Aims: The AXIOS stent is a lumen-apposing metal stent widely used for EUS-guided drainage of pancreatic fluid collections, biliary drainage, and gastroenterostomy. We analyzed device problems and patient adverse events reported to the FDA MAUDE database (2020–2025) with indication-specific risk stratification.

Methods

We performed a retrospective analysis of 1,775 AXIOS adverse event reports from the FDA MAUDE database, systematically classified by procedural indication, device problem, and patient outcome. Each report was assigned to a single highest-severity category, and within-indication proportions were calculated.