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 IN THE TRANSGASTRIC TO TREAT PANCREAS CYST THROUGH WALLED OF NECROSIS (WON) DURING AN ENDOSCOPIC ULTRASOUND (EUS) PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE FIRST FLANGE DID NOT OPEN; NOT OPENING WAS VISIBLE ON THE X-RAY. THE PHYSICIAN WAITED TO SEE IF ISSUE WOULD RESOLVE BUT THEN MOVE THE SYSTEM BACK AND FORTH. WHEN THE SECOND FLANGE WAS OPENED, THE FIRST FLANGE BURST AND ENDED UP IN THE STOMACH. THE PHYSICIAN ALSO REPORTED THAT THE FIRST FLANGE DID NOT OPEN UNTIL AFTER THE SECOND FLANGE HAD OPENED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE.

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. BLOCK H11: INVESTIGATION RESULTS: BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC COULD NOT CONFIRM THE REPORTED EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND AND STENT POSITIONING ISSUE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. HOWEVER, STENT POSITIONING ISSUE IS NOTED WITHIN THE PRODUCT LABELING AS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE. THERE IS NOT ENOUGH EVIDENCE TO DETERMINE WHETHER THE STENT FIRST FLANGE FAILURE TO EXPAND WAS DUE TO THE PHYSICIAN'S DEVICE MANIPULATION DURING THE PROCEDURE OR RELATED TO A DEVICE MALFUNCTION. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE; HOWEVER, RESPONSE WAS NOT RECEIVED. DEVICE HISTORY RECORD REVIEW: 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. LABELING REVIEW: A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL. ADDITIONALLY, STENT POSITIONING ISSUE IS NOTED WITHIN THE PRODUCT LABELING AS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF STENT FIRST FLANGE FAILURE TO EXPAND AND STENT POSITIONING ISSUE WERE DEFINED IN THE RISK DOCUMENTATION AND ARE DOCUMENTED ACCORDINGLY IN THE PRR. THESE EVENT TYPES HAVE BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE INVESTIGATION CONCLUDED THAT THE MOST PROBABLE CAUSE IS KNOWN INHERENT RISK OF DEVICE.

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 TRANSGASTRIC TO TREAT PANCREAS CYST THROUGH WALLED OF NECROSIS (WON) DURING AN ENDOSCOPIC ULTRASOUND (EUS) PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE FIRST FLANGE DID NOT OPEN; NOT OPENING WAS VISIBLE ON THE X-RAY. THE PHYSICIAN WAITED TO SEE IF ISSUE WOULD RESOLVE BUT THEN MOVE THE SYSTEM BACK AND FORTH. WHEN THE SECOND FLANGE WAS OPENED, THE FIRST FLANGE BURST AND ENDED UP IN THE STOMACH. THE PHYSICIAN ALSO REPORTED THAT THE FIRST FLANGE DID NOT OPEN UNTIL AFTER THE SECOND FLANGE HAD OPENED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.