AXIOS?

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO EXPAND. BLOCK H11: INVESTIGATION RESULTS: BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC COULD NOT CONFIRM THE REPORTED EVENT OF STENT FAILURE TO EXPAND. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION THE INVESTIGATION CONCLUDED THAT THERE IS NOT ENOUGH EVIDENCE TO DETERMINE IF THE REPORTED EVENT OF STENT FAILURE TO EXPAND WAS DUE TO THE PHYSICIAN'S MANIPULATION/TECHNIQUE DURING THE PROCEDURE, OR WHETHER IT WAS RELATED TO A DEVICE MALFUNCTION. DEVICE HISTORY RECORD: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DEVICE TECHNICAL ANALYSIS: THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED. INVESTIGATION CONCLUSION BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF UNABLE TO EXCLUDE DEVICE PROBLEM.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TRANSGASTRIC TO THE PANCREAS TO TREAT A WALLED-OFF-NECROSIS (WON) DURING A GASTRIC-CYST BYPASS SURGERY PROCEDURE PERFORMED ON (B)(6) 2025. REPORTEDLY, THE STENT DID NOT FULLY EXPAND DURING THE INITIAL IMPLANTATION PROCEDURE; HOWEVER, IT WAS LEFT IN PLACE. ON (B)(6) 2025, APPROXIMATELY ONE WEEK FOLLOWING STENT PLACEMENT, A FOLLOW-UP NECROSECTOMY PROCEDURE WAS ATTEMPTED. AT THAT TIME, THE STENT WAS STILL NOT ADEQUATELY EXPANDED TO ITS INTENDED 15 MM DIAMETER AND WAS ESTIMATED TO HAVE EXPANDED TO APPROXIMATELY 7-8 MM. AS A RESULT, THE ENDOSCOPE COULD NOT BE ADVANCED THROUGH THE STENT. BALLOON DILATION WAS PERFORMED TO FACILITATE SCOPE PASSAGE, AFTER WHICH NECROSECTOMY WAS COMPLETED. DRAINAGE WAS PRESENT, AND THE CYST WAS REPORTED TO BE DECREASING IN SIZE. NECROSECTOMY TREATMENT REMAINS ONGOING. THE STENT REMAINS IMPLANTED. THERE WAS NO ADVERSE EVENT REPORTED DUE TO THIS EVENT.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TRANSGASTRIC TO THE PANCREAS TO TREAT A WALLED-OFF-NECROSIS (WON) DURING A GASTRIC-CYST BYPASS SURGERY PROCEDURE PERFORMED ON (B)(6) 2025. REPORTEDLY, THE STENT DID NOT FULLY EXPAND DURING THE INITIAL IMPLANTATION PROCEDURE; HOWEVER, IT WAS LEFT IN PLACE. ON (B)(6) 2025, APPROXIMATELY ONE WEEK FOLLOWING STENT PLACEMENT, A FOLLOW-UP NECROSECTOMY PROCEDURE WAS ATTEMPTED. AT THAT TIME, THE STENT WAS STILL NOT ADEQUATELY EXPANDED TO ITS INTENDED 15 MM DIAMETER AND WAS ESTIMATED TO HAVE EXPANDED TO APPROXIMATELY 7-8 MM. AS A RESULT, THE ENDOSCOPE COULD NOT BE ADVANCED THROUGH THE STENT. BALLOON DILATION WAS PERFORMED TO FACILITATE SCOPE PASSAGE, AFTER WHICH NECROSECTOMY WAS COMPLETED. DRAINAGE WAS PRESENT, AND THE CYST WAS REPORTED TO BE DECREASING IN SIZE. NECROSECTOMY TREATMENT REMAINS ONGOING. THE STENT REMAINS IMPLANTED. THERE WAS NO ADVERSE EVENT REPORTED DUE TO THIS EVENT.