AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

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 TRANSGASTRIC TO FACILITATE A PSEUDOCYST DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) 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 1:1 FASHION. DURING THE PROCEDURE, A LARGE TARGET WAS IDENTIFIED VIA EUS. UPON DISTAL FLANGE DEPLOYMENT, IT WAS DIFFICULT TO VISUALIZE THE FLANGE AND ITS EXPANSION. THE PROXIMAL FLANGE WAS DEPLOYED, BUT A MISDEPLOYMENT WAS DETECTED, AND THE STENT WAS SUBSEQUENTLY RETRIEVED. TO ADDRESS THE ISSUE, THE PHYSICIAN ATTEMPTED TO DEPLOY A SECOND AXIOS AFTER INJECTING WITH FNA; HOWEVER, THE PSEUDOCYST DRAINED, MAKING PLACEMENT OF A NEW STENT UNSAFE. IT WAS THEREFORE DECIDED TO ABANDON STENT PLACEMENT AND LEFT IT TO DRAIN NATURALLY. ALTHOUGH NO COMPLICATIONS WERE REPORTED IN THE PATIENT, IT WAS NOTED THAT AFTER STENT REMOVAL THE PATIENT WAS TREATED WITH ANTIBIOTICS AND SENT FOR FOLLOW UP IMAGING. THE PATIENT WAS KEPT IN THE HOSPITAL FOR OBSERVATION AND IS EXPECTED TO MAKE A FULL RECOVERY.

Additional Manufacturer Narrative

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. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED (FNA NEEDLING) IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED (ANTIBIOTICS). IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF IMAGING REQUIRED. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION. IMDRF IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF CANCELLED PROCEDURE.