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.

Results

Annual reports increased 232% from 144 (2020) to 478 (2025). Indications comprised pancreatic drainage (46.2%), biliary drainage (35.7%), and gastroenterostomy (9.5%). Device problems included positioning/malpositioning (59.0%), distal flange activation failure (19.4%), migration (7.3%), and proximal detachment (4.5%). Gastroenterostomy carried the highest within-indication proportions of mortality (11.8%), perforation (6.5%), and infection (4.1%), exceeding biliary (3.9%, 6.3%, 1.4%) and pancreatic drainage (2.3%, 3.7%, 1.5%).