AXIOS?

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF THE ADDITIONAL INTERVENTION REQUIRED TO REMOVE THE STENT.

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 PANCREATIC CYST GASTRIC BYPASS SURGERY PERFORMED ON (B)(6) 2026. ON (B)(6) 2026, ONE-WEEK POST STENT PLACEMENT, DURING A NECROSECTOMY PROCEDURE, GRANULATION-LIKE TISSUE WAS OBSERVED FORMING WITHIN THE PROSTHETIC MATERIAL UNDER ENDOSCOPIC VISUALIZATION. THE ORIGINAL STENT WAS REMOVED USING FORCEPS, AND A DIFFERENT DEVICE WAS SUBSEQUENTLY IMPLANTED SUCCESSFULLY. THERE WAS NO ADVERSE EVENT REPORTED DUE TO THIS EVENT.

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 PANCREATIC CYST GASTRIC BYPASS SURGERY PERFORMED ON (B)(6) 2026. ON JANUARY 22, 2026, ONE-WEEK POST STENT PLACEMENT, DURING A NECROSECTOMY PROCEDURE, GRANULATION-LIKE TISSUE WAS OBSERVED FORMING WITHIN THE PROSTHETIC MATERIAL UNDER ENDOSCOPIC VISUALIZATION. THE ORIGINAL STENT WAS REMOVED USING FORCEPS, AND A DIFFERENT DEVICE WAS SUBSEQUENTLY IMPLANTED SUCCESSFULLY. THERE WAS NO ADVERSE EVENT REPORTED DUE TO THIS EVENT.

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF THE ADDITIONAL INTERVENTION REQUIRED TO REMOVE THE STENT. BLOCK H11: INVESTIGATION RESULTS: BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC WAS ABLE TO CONFIRM THE REPORTED EVENT OF STENT OBSTRUCTION WITHIN DEVICE BASED ON MEDIA REVIEW OF THE PHOTO PROVIDED, WHICH INDICATED TISSUE INGROWTH WITHIN THE STENT. STENT OBSTRUCTION WITHIN DEVICE IS ALSO NOTED WITHIN THE IFU AS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE. 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: AN AXIOS STENT WAS RECEIVED FOR ANALYSIS; THE DELIVERY SYSTEM WAS NOT RETURNED. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE STENT WIRE WAS BROKEN AND THAT THE STENT COVER WAS INTACT. MEDIA REVIEW OF THE PHOTO PROVIDED BY THE COMPLAINANT INDICATED TISSUE INGROWTH WITHIN THE STENT. NO OTHER ISSUES WERE NOTED TO THE STENT. LABELING REVIEW: 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. ADDITIONALLY, STENT OBSTRUCTION WITHIN DEVICE IS NOTED WITHIN THE INSTRUCTIONS FOR USE (IFU) AS A KNOWN POSSIBLE ADVERSE EVENT RELATED TO THE USE OF THE DEVICE. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE REPORTED EVENT OF STENT OBSTRUCTION WITHIN DEVICE WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.