AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO EXPAND. IMDRF PATIENT CODE E2338 CAPTURES THE REPORTABLE EVENT OF EDEMA. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF FORCEPS WERE USED TO CLAMP THE EDGE OF THE SECOND FLANGE, AND THE STENT WAS REMOVED. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF THE PATIENT REMAINED HOSPITALIZED FOR TWO DAYS TO ALLOW THE GASTRIC WALL TO RETURN TO ITS NORMAL STATE. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF A SECOND PROCEDURE WAS PERFORMED TWO DAYS LATER AFTER THE PROCEDURE. BLOCK H11: BOSTON SCIENTIFIC IS INITIATING A REMOVAL OF CERTAIN SIZES OF THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM (6MM X 8MM, 8MM X 8MM AND 20MM X 10MM) MANUFACTURED SINCE MARCH 1, 2025. THIS ACTION IS BEING TAKEN DUE TO INCREASED REPORTS OF STENT DEPLOYMENT AND EXPANSION ISSUES WITH THESE CONFIGURATIONS. THESE ISSUES ONLY OCCUR AT THE TIME OF STENT DELIVERY AND ARE EXPECTED TO BE NOTICED BY THE PHYSICIAN. PATIENTS WHO HAVE BEEN TREATED WITH A SUCCESSFULLY IMPLANTED AXIOS STENT SHOULD CONTINUE TO FOLLOW STANDARD OF CARE AND ARE NOT AFFECTED BY THIS ISSUE. A LETTER WAS SENT OUT TO MATERIALS MANAGERS/HEALTH CARE PROFESSIONALS ON 19-DEC-2025 TO IMMEDIATELY STOP FURTHER DISTRIBUTION OR USE OF ANY AFFECTED 6MM X 8MM, 8MM X 8MM AND 20MM X 10MM AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM. THE LETTER INDICATES TO REMOVE THESE DEVICES FROM INVENTORY AND SEGREGATE THEM IN A SECURE LOCATION UNTIL THEY CAN BE RETURNED TO BOSTON SCIENTIFIC. THE REFERENCED AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM MET ALL SPECIFICATIONS PRIOR TO FINAL APPROVAL FOR DISTRIBUTIONS/SALE.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO PANCREAS TO TREAT AN ENCAPSULATED NECROSIS OF THE PANCREAS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE AXIOS STENT FIRST FLANGE WAS NOT CLEARLY VISIBLE UNDER ULTRASOUND AS NO HYPERECHOIC SIGNAL WAS OBSERVED. A 19G PUNCTURE NEEDLE WAS THEN USED TO PUNCTURE AND INFUSE FLUID INTO THE CYSTIC CAVITY TO ENSURE IT WAS MORE DISTENDED. HOWEVER, NO HYPERECHOIC SIGNAL WAS STILL OBSERVED UNDER ULTRASOUND DURING SECOND ATTEMPT OF DEPLOYMENT, BUT FLUOROSCOPY SHOWED THAT THE FIRST FLANGE WAS NOT FULLY EXPANDED AND APPEARED SPINDLE SHAPED. THE STENT WAS REMOVED AND REASSEMBLED. DURING A THIRD ATTEMPTED DEPLOYMENT, THE STENT WAS FULLY DEPLOYED BUT THE STENT FIRST FLANGE WAS STILL NOT FULLY EXPANDED. FORCEPS WERE THEN USED TO CLAMP THE EDGE OF THE SECOND FLANGE, AND THE STENT WAS REMOVED. DURING THE PUNCTURE PROCESS, IT WAS NOTED THAT THE GASTRIC WALL WAS EDEMATOUS DUE TO REPEATED INSTRUMENT MANIPULATION, WHICH IS AN EXPECTED RESPONSE, AND MADE AXIOS STENT PLACEMENT NO LONGER SUITABLE. THE PATIENT REMAINED HOSPITALIZED FOR TWO DAYS TO ALLOW THE GASTRIC WALL TO RETURN TO ITS NORMAL STATE, AND THEN A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2025, IN WHICH A NEW AXIOS DEVICE WAS IMPLANTED. AFTER THE FIRST PUNCTURE ON THE (B)(6), ELECTROCOAGULATION HEMOSTASIS WAS PERFORMED TO CLOSE IT WITHOUT USING HEMOSTATIC CLIPS. THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.