AXIOS Stent and Electrocautery Enhanced Delivery System

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF STENT PARTIALLY DEPLOYED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE BILIARY DUCT TO FACILITATE BILIARY DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2026. REPORTEDLY, THE PHYSICIAN WAS USING THE EUS METHOD OF DEPLOYMENT WHERE THE SECOND FLANGE OF THE STENT IS DEPLOYED IN THE SCOPE, AND THEN THE STENT IS RELEASED FROM THE SCOPE BY ADVANCING THE CATHETER AND RETRACTING THE SCOPE IN A 1TO1 FASHION. DURING THE PROCEDURE, THE PHYSICIAN REPORTED WHEN ATTEMPTING TO IMPLANT THE STENT THE FIRST FLANGE WAS ABLE TO BE DEPLOYED BUT THE STENT MOVED. THE MANIPULATOR TRIED TO PASS A JAGWIRE GUIDEWIRE THROUGH THE WORKING CHANNEL, BUT IT WAS UNSUCCESSFUL. THE SECOND FLANGE WAS IMPOSSIBLE TO OPEN. THE PROCEDURE WAS ABLE TO BE COMPLETED BY USING ANOTHER BILIARY WALLFLEX STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.