Abstract / Summary
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%). Conclusions: AXIOS adverse event reporting increased 232% from 2020–2025, reflecting expanding utilization and enhanced surveillance. Gastroenterostomy carried the highest within-indication burden of serious adverse events. The marked rise in distal flange activation failures—coinciding with December 2025 manufacturer field safety notice— demonstrates postmarketing surveillance value and underscores the need for indication-specific risk stratification and prospective registries capturing operator-level and device-level detail that passive surveillance cannot provide.