AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Additional Manufacturer Narrative

BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE COMPLAINT DEVICE LOT NUMBER. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY. BLOCK H11: FOLLOWING AN UPDATE TO THE AXIOS RISK DOCUMENTATION, THIS EVENT IS BEING REPORTED AS PART OF THE EFFORTS ASSOCIATED WITH BOSTON SCIENTIFIC'S NONCONFORMING EVENTS AND PREVENTION INVESTIGATION, (B)(4). INVESTIGATIONS RESULTS: BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CORPORATION CONFIRMED THE REPORTED EVENTS OF STENT FAILURE TO DEPLOY AND SHEATH BREAK. THE SHEATH CONDITION IMPEDED THE STENT FROM BEING DEPLOYED. THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENTS WERE MOST LIKELY CAUSED BY PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE AND THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED). IT WAS REPORTED THAT THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN EITHER THE PYLORIS AREA OR THE ESOPHAGUS. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS 6 CM IN SIZE AND WALLED-OFF NECROSIS 6 CM IN SIZE THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE STENT IS NOT INTENDED TO BE IMPLANTED IN NEITHER OF THE MENTIONED ANATOMIES. DEVICE HISTORY REVIEW: A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICE COULD NOT BE PERFORMED SINCE THE LOT NUMBER INFORMATION WAS NOT AVAILABLE. DEVICE TECHNICAL ANALYSIS: AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION IDENTIFIED THE STENT WAS FULLY COVERED AND UNDEPLOYED. DURING DEVICE EVALUATION, THE OUTER SHEATH WAS OBSERVED TO BE DETACHED NEAR THE LUER SECTION. LABEL REVIEW: A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE, THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU)/PRODUCT LABEL. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF "STENT FAILURE TO DEPLOY" 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 COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF ADVERSE EVENT RELATED TO PROCEDURE.

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 IN EITHER THE PYLORIS AREA OR THE ESOPHAGUS DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE STENT FAILED TO BE DEPLOYED AND THE SHEATH BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN EITHER THE PYLORIS AREA OR THE ESOPHAGUS. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS 6 CM IN SIZE AND WALLED-OFF NECROSIS 6 CM IN SIZE THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE STENT IS NOT INTENDED TO BE IMPLANTED IN NEITHER OF THE MENTIONED ANATOMIES.