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 TREAT PANCREATIC PSEUDOCYST WITH WALLED OF NECROSIS (WON) 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 1:1 FASHION. DURING THE PROCEDURE, IT WAS REPORTED THAT THE STENT COULD NOT BE FULLY DEPLOYED. THE FIRST FLANGE WAS SUCCESSFULLY RELEASED, BUT THE SECOND FLANGE FAILED TO DETACH FROM THE CATHETER AND DID NOT DEPLOY COMPLETELY. UPON DEPLOYMENT OF THE FLANGES OF THE AXIOS STENT, THE PATIENT EXPERIENCED RAPID DRAINAGE; HOWEVER, THE STENT SUBSEQUENTLY MIGRATED INTO THE STOMACH. THEREFORE, THE STENT WAS REMOVED USING RETRIEVAL FORCEPS. ADDITIONALLY, RESISTANCE WAS ALSO NOTED IN THE CATHETER DURING THE ATTEMPT TO RELEASE THE SECOND FLANGE. FOUR DAYS LATER, A SECOND PROCEDURE WAS PERFORMED. BY THAT TIME, PORTIONS OF THE COLLECTION HAD ALREADY DECREASED IN SIZE, MAKING THE PLACEMENT OF A NEW AXIOS STENT UNNECESSARY. AT THE SITE, NECROTIC TISSUE WAS OBSERVED, WITH ONLY MINIMAL FLUID REMAINING FOR DRAINAGE. THE PHYSICIAN LEFT THE PUNCTURE SITE OPEN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONTINUED TO PROGRESS WELL, EVEN WITHOUT THE AXIOS STENT REMAINING IN PLACE. UPON REASSESSMENT THREE DAYS LATER, THE SPECIFIC COLLECTION THAT HAD BEEN RAPIDLY DRAINED WAS ALREADY SIGNIFICANTLY REDUCED IN SIZE.

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF STENT PARTIALLY DEPLOY. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED.