AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Additional Manufacturer Narrative

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). INVESTIGATION RESULTS: WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CORPORATION CONFIRMED THE REPORTED EVENT OF STENT FAILURE TO DEPLOY. DESTRUCTIVE TESTING IDENTIFIED THE SHEATH DETACHED FROM THE HANDLE SECTION CAUSED BY ROTATIONAL DAMAGE, IMPEDING STENT DEPLOYMENT. DEVICE HISTORY RECORDS REVIEW: BOSTON SCIENTIFIC REVIEWED THE DEVICE HISTORY RECORD, WHICH INCLUDED MANUFACTURING DOCUMENTATION, AND DID NOT IDENTIFY ANY ANOMALIES OR DEVIATIONS THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. DEVICE TECHNICAL ANALYSIS: AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL INSPECTION WAS PERFORMED. THE STENT WAS RETURNED FULLY COVERED AND UNDEPLOYED. THE OUTER SHEATH WAS OBSERVED KINKED IN THE DISTAL SECTION, AND THE DELIVERY SYSTEM WAS RETURNED IN POSITION 4 OF THE DEPLOYMENT PROCESS. NO ADDITIONAL DAMAGE WAS OBSERVED DURING THE VISUAL INSPECTION. A FUNCTIONAL INSPECTION WAS SUBSEQUENTLY PERFORMED TO EVALUATE CATHETER LOCK FUNCTIONALITY. DURING MANIPULATION OF THE DEPLOYMENT HUB, THE STENT COULD NOT BE RELEASED FROM THE DELIVERY SYSTEM. A DESTRUCTIVE EVALUATION WAS THEREFORE REQUIRED TO FURTHER ASSESS THE OUTER SHEATH IN THE HANDLE SECTION. THE DESTRUCTIVE ANALYSIS CONFIRMED TORSION (ROTATIONAL) DAMAGE TO THE OUTER SHEATH, RESULTING IN SHEATH DETACHMENT WITHIN THE HANDLE SECTION. LABELING 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. THE IFU STATES: "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE." HOWEVER, ACCORDING TO THE PRODUCT ANALYSIS, THE OUTER SHEATH WAS RETURNED DETACHED FROM THE HANDLE SECTION CAUSED BY ROTATIONAL DAMAGE, WHICH IS EVIDENCE THE LUER WAS INCORRECTLY ROTATED. 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 REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF FAILURE TO FOLLOW INSTRUCTIONS.

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 THE CYST AREA TO PERFORM A PSEUDOCYST DRAINAGE PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PHYSICIAN COULD NOT DEPLOY THE STENT AT THE FIRST FLANGE, THE STENT STAYED COMPLETELY COVERED IN THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.