AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Description of Event or Problem

PROCEDURE SUMMARY: IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TRANSGASTRICALLY DURING AN ENDOSCOPIC ULTRASOUND-GUIDED GASTROENTEROSTOMY (EUS-GE) PERFORMED ON (B)(6) 2026. EVENT SUMMARY: DURING THE PROCEDURE, THE AXIOS STENT WAS FULLY DEPLOYED; HOWEVER, THE STENT EXPANDED ONLY TO 9 MM INSTEAD OF 15 MM. THE STENT REMAINS IN PLACE, AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS ATTEMPTED TO BE IMPLANTED FOR A GASTROENTEROSTOMY PROCEDURE. THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH GREATER THAN OR EQUAL TO 70% FLUID CONTENT, GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY AND BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE. THE DEVICE IS NOT INDICATED FOR PLACEMENT DURING GASTROENTEROSTOMY PROCEDURE.

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO EXPAND.