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

Abstract

Abstract Background and Aims The AXIOS stent is a lumen-apposing metal stent widely used for endoscopic ultrasound-guided drainage of pancreatic fluid collections, biliary drainage, and gastroenterostomy. We analyzed device problems and patient adverse events reported to the FDA Manufacturer and User Facility Device Experience (MAUDE) database (2020–2025) with indication-specific risk stratification. Methods We performed a retrospective analysis of 1775 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 by 232%, from 144 in 2020 to 478 in 2025. The 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 by 232% from 2020 to 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- and device-level detail that passive surveillance cannot provide.