AXIOS?

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 PANCREATIC PSEUDOCYST DURING A CYSTGASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2026. THE PHYSICIAN WAS USING THE EUS METHOD OF DEPLOYMENT WHERE THE SECOND FLANGE OF THE STENT IS DEPLOYED IN THE SCOPE, AND THEN THE STENT IS RELEASED FROM THE SCOPE BY ADVANCING THE CATHETER AND RETRACTING THE SCOPE IN A 1:1 FASHION. DURING THE PROCEDURE, THE PROXIMAL FLANGE WAS DEPLOYED, BUT THE FLANGE WAS SLOW TO EXPAND. THE PHYSICIAN ATTEMPTED TO MANIPULATE THE CATHETER AS PART OF TROUBLESHOOTING; HOWEVER, WHILE THE CATHETER WAS BEING RETRACTED INTO THE SCOPE, THE STENT SHIFTED FROM ITS INTENDED POSITION AND ENTERED THE GASTRIC WALL. THE STENT REMAINS IMPLANTED, AND A DIFFERENT SIZED AXIOS STENT, ALONG WITH A PLASTIC STENT, WAS SUBSEQUENTLY PLACED WITHIN THE ORIGINAL AXIOS STENT TO COMPLETE THE PROCEDURE WITH THE USE OF A GUIDEWIRE. A NECROSECTOMY PROCEDURE WAS SCHEDULED FOR (B)(6) 2026, AT WHICH TIME IT WAS CONFIRMED THAT THE STENT REMAINED IMPLANTED BETWEEN THE STOMACH AND THE CYST. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS NOTED TO BE FULLY RECOVERED.

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE.

Additional Manufacturer Narrative

BLOCKS B1, B2 AND H1 HAVE BEEN CORRECTED. BLOCK H6: 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 POSITIONING ISSUE. HOWEVER, STENT POSITIONING ISSUE IS NOTED WITHIN THE INSTRUCTIONS FOR USE (IFU) AS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. WITHOUT A PROPER EVALUATION OF THE DEVICE, THE MOST PROBABLE CAUSE CONTRIBUTING TO THE EVENT COULD NOT BE DETERMINED. 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: THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, A PRODUCT ANALYSIS COULD NOT BE PERFORMED. HOWEVER, IMAGES WERE PROVIDED THAT SHOW THE AXIOS STENT IMPLANTED WITHIN THE PATIENT'S ANATOMY, AS WELL AS PHOTOS OF THE PRODUCT PACKAGING, INCLUDING THE PRODUCT LABEL AND ASSOCIATED PRODUCT INFORMATION. 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 POSITIONING ISSUE IS NOTED WITHIN THE 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 POSITIONING ISSUE 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 UNABLE TO EXCLUDE DEVICE PROBLEM.

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 PANCREATIC PSEUDOCYST DURING A CYSTGASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2026. THE PHYSICIAN WAS USING THE EUS METHOD OF DEPLOYMENT WHERE THE SECOND FLANGE OF THE STENT IS DEPLOYED IN THE SCOPE, AND THEN THE STENT IS RELEASED FROM THE SCOPE BY ADVANCING THE CATHETER AND RETRACTING THE SCOPE IN A 1:1 FASHION. DURING THE PROCEDURE, THE PROXIMAL FLANGE WAS DEPLOYED, BUT THE FLANGE WAS SLOW TO EXPAND. THE PHYSICIAN ATTEMPTED TO MANIPULATE THE CATHETER AS PART OF TROUBLESHOOTING; HOWEVER, WHILE THE CATHETER WAS BEING RETRACTED INTO THE SCOPE, THE STENT SHIFTED FROM ITS INTENDED POSITION AND ENTERED THE GASTRIC WALL. THE STENT REMAINS IMPLANTED, AND A DIFFERENT SIZED AXIOS STENT, ALONG WITH A PLASTIC STENT, WAS SUBSEQUENTLY PLACED WITHIN THE ORIGINAL AXIOS STENT TO COMPLETE THE PROCEDURE WITH THE USE OF A GUIDEWIRE. A NECROSECTOMY PROCEDURE WAS SCHEDULED FOR (B)(6) 2026, AT WHICH TIME IT WAS CONFIRMED THAT THE STENT REMAINED IMPLANTED BETWEEN THE STOMACH AND THE CYST. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS NOTED TO BE FULLY RECOVERED.