AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Additional Manufacturer Narrative

BLOCK E1: INITIAL REPORTER FIRST NAME: CHARLES KIEN FONG; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF DEVICE CODE A090814 CAPTURES THE REPORTABLE EVENT OF STENT NOT VISIBLE UNDER EUS OR FLUOROSCOPY.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO COMMON BILE DUCT DURING A COMMON BILE DUCT (CBD) EXPLORATION WITH CHOLECYSTO DUODENOSTOMY (CDS) PROCEDURE PERFORMED ON (B)(6), 2026. DURING THE PROCEDURE, SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING DEPLOYMENT, AND EUS IMAGING DID NOT CLEARLY CONFIRM WHETHER THE STENT WAS POSITIONED AGAINST THE WALL OR WITHIN THE BILE DUCT. A GUIDEWIRE WAS SUBSEQUENTLY INSERTED DUE TO SUSPECTED MALDEPLOYMENT. THE PHYSICIAN THEN PROCEEDED WITH DEPLOYMENT OF THE PROXIMAL FLANGE AND PLACED AN ADDITIONAL WALLFLEX BILIARY FULLY COVERED STENT TO ENSURE AND MAINTAIN DUCTAL PATENCY. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.