AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Additional Manufacturer Narrative

BLOCK H6: IMDRF IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF CANCELED PROCEDURE.

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 BETWEEN THE STOMACH AND THE SMALL BOWEL TO TREAT PANCREATIC CANCER DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE ELECTROCAUTERY FAILED WHILE ATTEMPTING TO BURN THROUGH THE WALL; TO RESOLVE THE ISSUE, THE PHYSICIAN USED A NON-BOSTON SCIENTIFIC STENT WITH CAUTERIZATION PROPERTIES, WHICH APPROPRIATELY PUNCTURE THE PATIENT. HOWEVER, THE FLANGE OF THIS DEVICE DID NOT OPEN. THE PROCEDURE WAS CANCELLED AND THE PUNCTURE WAS CLOSED USING AND OVERSO CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED DURING A GASTRO-ENTERO ANASTOMOSIS PROCEDURE. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH AT LEAST 70 PERCENT OF FLUID CONTENT, GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY AND BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE. THE DEVICE IS NOT INDICATED TO TREAT PANCREATIC CANCER DURING A GASTRO-ENTERO ANASTOMOSIS.

Additional Manufacturer Narrative

BLOCK B3: DATE OF EVENT HAS BEEN CORRECTED TO MARCH 1ST, 2026. THE DATE OF EVENT WAS NOT PROVIDED. HOWEVER, 03/01/2026 WAS SELECTED AS THE ESTIMATED EVENT DATE BASED ON THE BSC AWARE DATE. BLOCK G4: PREMARKET / 510(K) # WAS CORRECTED. BLOCK H6: IMDRF IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF CANCELED PROCEDURE. BLOCK H11: INVESTIGATION RESULTS: WITH ALL AVAILABLE INFORMATION, BOSTON SCIENTIFIC CORPORATION CONCLUDES THAT THE REPORTED EVENT OF CAUTERY FAILURE TO DELIVER ENERGY WAS NOT ABLE TO BE CONFIRMED. THE AXIOS DEVICE WAS RETURNED WITH THE SLIDER DETACHED AND NOT RETURNED; WHICH INDICATES THAT THE FAILURE IS A RANDOM OR EXPECTED FAILURE OF THE DEVICE COMPONENT, IN THIS CASE THE SLIDER DETACHING FROM THE HANDLE. ADHESIVE WAS NOTED ON THE INNER SHEATH. ADDITIONALLY, BUBBLES WERE OBSERVED WHEN THE DEVICE WAS CONNECTED TO THE ERBE SYSTEM AND ELECTRICAL TESTING CONFIRMED THERE IS CONTINUITY IN THE CIRCUIT. REGARDING THE EVENT "CANCELLED/RESCHEDULED - POST SEDATION/SEDATION UNKNOWN", IT CANNOT BE CONFIRMED AS IT OCCURRED DURING THE PROCEDURE. THERE IS NOT AN OBJECTIVE EVIDENCE OR DESCRIPTIVE CONDITIONS TO ESTABLISH THE CAUSE OF THE REPORTED EVENT. 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. DEVICE TECHNICAL ANALYSIS: THE DEVICE HAS BEEN RETURNED, AND WHILE DOING THE PRODUCT ANALYSIS, IT WAS NOTED THAT THE SLIDER WAS DETACHED AND NOT RETURNED. RADIOGRAPH IMAGES CONFIRMED THE STENT WAS DEPLOYED AND NOT RETURNED. THE SHEATH WAS MANUALLY RETRACTED; ADHESIVE WAS NOTED ON THE INNER SHEATH. VISUAL INSPECTION OBSERVED NO DAMAGES TO THE HANDLE OR SHEATH. FUNCTIONAL TESTING WAS PERFORMED BY CONNECTING THE HANDLE TO THE ERBE CONSOLE AND SUBMERGING THE DISTAL TIP IN A BEAKER FILLED WITH SALINE SOLUTION. WHEN ENERGIZED, BUBBLES WERE OBSERVED INDICATING THE CAUTERY SYSTEM IS FUNCTIONING. ELECTRICAL TESTING WAS CONDUCTED BY VERIFYING CONTINUITY BETWEEN THE RF CONNECTOR AND DISTAL RF ELECTRODE USING A MULTIMETER. TEST PROBES WERE CONNECTED TO THE MONOPOLAR PLUG AND THE CAUTERY WIRE IN THE NOSE CONE. A CLOSED CIRCUIT WAS CONFIRMED, AND THE MEASURED RESISTANCE WAS 2.0 OHMS. THIS MEETS THE PASSING CRITERIA OF RESISTANCE LESS THAN 4 OHMS PER PROCEDURE. LABELING REVIEW: THE LABELING REVIEW FOUND EVIDENCE TO SUGGEST THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELLED INDICATIONS. IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED DURING A GASTRO-ENTERO ANASTOMOSIS PROCEDURE. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH AT LEAST 70 PERCENT OF FLUID CONTENT, GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY AND BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE. THE DEVICE IS NOT INDICATED TO TREAT PANCREATIC CANCER DURING A GASTRO-ENTERO ANASTOMOSIS. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF "STENT FAILURE TO DEPLOY, DEVICE USE OF DEVICE ISSUE - MISUSE AND CANCELLED/RESCHEDULED - POST SEDATION/SEDATION UNKNOWN" WERE DEFINED IN THE RISK DOCUMENTATION. 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 NO PROBLEM DETECTED.

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 BETWEEN THE STOMACH AND THE SMALL BOWEL TO TREAT PANCREATIC CANCER DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE ELECTROCAUTERY FAILED WHILE ATTEMPTING TO BURN THROUGH THE WALL; TO RESOLVE THE ISSUE, THE PHYSICIAN USED A NON-BOSTON SCIENTIFIC STENT WITH CAUTERIZATION PROPERTIES, WHICH APPROPRIATELY PUNCTURE THE PATIENT. HOWEVER, THE FLANGE OF THIS DEVICE DID NOT OPEN. THE PROCEDURE WAS CANCELLED AND THE PUNCTURE WAS CLOSED USING AND OVESCO CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED DURING A GASTRO-ENTERO ANASTOMOSIS PROCEDURE. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH AT LEAST 70 PERCENT OF FLUID CONTENT, GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY AND BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE. THE DEVICE IS NOT INDICATED TO TREAT PANCREATIC CANCER DURING A GASTRO-ENTERO ANASTOMOSIS.