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. BLOCK H11: AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS NOT RETURNED FOR ANALYSIS. HOWEVER, SAMPLE PHOTOGRAPHS WERE PROVIDED WHERE IT CAN BE OBSERVED THAT THE STENT WAS NOT FULLY EXPANDED. THE REPORTED EVENT OF STENT FAILURE TO EXPAND WAS CONFIRMED BASED ON MEDIA ANALYSIS DONE ON THE PROVIDED PHOTOGRAPHS. HOWEVER, WITH THE INFORMATION AVAILABLE AND WITHOUT PROPER EVALUATION OF THE DEVICE, THERE IS NOT ENOUGH EVIDENCE TO DETERMINE WHETHER THE REPORTED FAILURE TO EXPAND WAS DUE TO THE PHYSICIAN'S MANIPULATION/TECHNIQUE DURING THE PROCEDURE OR RELATED TO A DEVICE MALFUNCTION. ADDITIONALLY, STENT EXPANSION RATES CAN BE ALSO NEGATIVELY IMPACTED BY THE FOLLOWING FACTORS: COMPRESSION, TIME, TEMPERATURE, AND HUMIDITY. THEREFORE, TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE INVESTIGATION CONCLUDED THAT THE MOST PROBABLE CAUSE IS UNABLE TO EXCLUDE DEVICE PROBLEM. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THERE IS NO INFORMATION THAT THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU)/PRODUCT LABEL.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TRANSDUODENAL TO THE PANCREAS TO TREAT A WALLED-OFF-NECROSIS (WON) DURING AN EUS-GUIDED ENDOSCOPIC DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED THE FIRST FLANGE; HOWEVER, IT DID NOT FULLY EXPAND. THE PHYSICIAN WAITED APPROXIMATELY TWO MINUTES TO ALLOW FOR POTENTIAL EXPANSION, BUT NO CHANGE WAS OBSERVED. THE SECOND FLANGE WAS THEN DEPLOYED, BUT IT ALSO DID NOT EXPAND. SUBSEQUENTLY, THE PHYSICIAN USED A GRASPER TO MOBILIZE THE AXIOS STENT, AFTER WHICH THE FLANGE EXPANDED. A DOUBLE-PIGTAIL STENT WAS THEN PLACED TO HELP PREVENT DEVICE MIGRATION. THE PHYSICIAN WAS COMFORTABLE LEAVING THE AXIOS STENT INSIDE THE PATIENT. THERE WAS NO PATIENT COMPLICATION REPORTED DUE TO THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS RECEIVED SHOWING THE COMPLAINT AXIOS STENT WITH ONE OF THE FLANGES NOT FULLY EXPANDED.

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 TRANSDUODENAL TO THE PANCREAS TO TREAT A WALLED-OFF-NECROSIS (WON) DURING AN EUS-GUIDED ENDOSCOPIC DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED THE FIRST FLANGE; HOWEVER, IT DID NOT FULLY EXPAND. THE PHYSICIAN WAITED APPROXIMATELY TWO MINUTES TO ALLOW FOR POTENTIAL EXPANSION, BUT NO CHANGE WAS OBSERVED. THE SECOND FLANGE WAS THEN DEPLOYED, BUT IT ALSO DID NOT EXPAND. SUBSEQUENTLY, THE PHYSICIAN USED A GRASPER TO MOBILIZE THE AXIOS STENT, AFTER WHICH THE FLANGE EXPANDED. A DOUBLE-PIGTAIL STENT WAS THEN PLACED TO HELP PREVENT DEVICE MIGRATION. THE PHYSICIAN WAS COMFORTABLE LEAVING THE AXIOS STENT INSIDE THE PATIENT. THERE WAS NO PATIENT COMPLICATION REPORTED DUE TO THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS RECEIVED SHOWING THE COMPLAINT AXIOS STENT WITH ONE OF THE FLANGES NOT FULLY EXPANDED.