Adverse events associated with AXIOS stents: Insights from the manufacturer and user facility device experience database

Background and objectives: The AXIOS stent is indicated for transgastric or transduodenal drainage of symptomatic pancreatic pseudocysts and symptomatic walled off necrosis. The AXIOS stent functions as a conduit which allows solid and liquid pancreatic fluid collections (PFC) contents to pass into the luminal GI tract and also allows the passage of standard and therapeutic endoscopes into the PFC to perform endoscopic debridement. We aim to investigate the number and type of complications associated with AXIOS stents. Materials and methods: We analyzed postmarketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database January 2016 to February 2021. Results: During the study period, approximately 588 reports with 579 device issues and 250 patient complications were identified. Most device complications were due to stent positioning problems or stent malpositioning (n = 206; 35.6%), followed by stent migration (n = 72; 12.4%), premature deployment (n = 61; 10.5%), material integrity (n = 56; 9.6%), deployment failure (n = 47; 8.1%), and difficulty removing the stent (n = 45; 7.7%). The most reported patient adverse events were hemorrhage/bleeding (n = 81; 32.4%), perforation (n = 26; 10.4%), pain (n = 22; 8.8%), unspecified infection (n = 20; 8.0%), and death (n = 17; 6.8%). Conclusions: Findings from the MAUDE database highlight patient and device complications which endoscopists should be aware of before AXIOS stent placement.