WALLSTENT ENDOPROSTHESIS

Description of Event or Problem

IT WAS REPORTED THAT STENT DAMAGE OCCURRED CAUSING PAIN AND VESSEL TRAUMA. THE TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN. A 14X90/9FR UNI PLUS 75CM WALLSTENT UNI STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS FOUND THAT THE TIP OF THE STENT WAS IRREGULAR IN SHAPE AND HAD ABNORMAL PROTRUDES, WHICH CAUSED SEVERE PAIN TO THE PATIENT. AFTER REMOVAL, IT WAS NOTED THAT THE VESSEL'S INTIMA HAD BEEN TORN AND DAMAGED, AND IT HAD BECOME ATTACHED TO THE STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT CONDITION WAS STABLE FOLLOWING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE 50% STENOSED TARGET LESION WAS NOTED. THE SHAPE OF THE STENT'S TIP END WAS IRREGULAR WITH ABNORMAL PROTRUSIONS. WHEN IT WAS RELEASED, THE PATIENT EXPERIENCED SEVERE PAIN. UPON WITHDRAWAL, IT WAS OBSERVED THAT THE INNER LINING OF THE BLOOD VESSEL WAS TORN AND DAMAGED AND THE ABNORMAL PROTRUDING STENT AND THERE WAS NO TREATMENT AVAILABLE FOR THE TIME BEING.

Additional Manufacturer Narrative

(B)(6). GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THAT THE CONTENT WAS SUFFICIENT AND DID NOT CONTRIBUTE TO THE REPORTED EVENT; THEREFORE, NO UPDATES ARE REQUIRED TO THE DOCUMENT AT THIS TIME. DEVICE HISTORY RECORD (DHR): IT WAS CONFIRMED THAT THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF STENT MATERIAL DEFORMATION, PAIN, AND VESSEL TRAUMA WERE DEFINED IN THE RISK DOCUMENTATION AND ARE DOCUMENTED ACCORDINGLY IN THE PRR. THESE EVENT TYPES HAVE BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. DEVICE TECHNICAL ANALYSIS: THE DEVICE WAS RETURNED WITH THE STENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. NO DAMAGE OR DEFORMATION WERE NOTED WITH THE STENT. FOREIGN MATERIAL (FM) WAS FOUND ON THE DISTAL END OF THE STENT. A VISUAL AND TACTILE EXAMINATION FOUND THE SHEATH OF THE DEVICE WAS KINKED AT APPROXIMATELY 95MM DISTAL FROM THE MAIN T VALVE. THE STENT DAMAGE COULD NOT BE CONFIRMED. THE SHEATH KINKING NOTED DURING DEVICE ANALYSIS MOST PROBABLY OCCURRED FROM USER TO DEVICE INTERACTION; HOWEVER, IT COULD NOT BE ESTABLISHED AT WHICH STAGE OF THE PROCEDURE IT OCCURRED (DURING PREPARATION/PROCEDURE/HANDLING POST PROCEDURE). IT WAS REPORTED THAT THE FM ON THE STENT WAS DUE TO THE PROCEDURAL EVENT OF THE VESSELS INTIMA BEING TORN AND DAMAGED AND BECOMING ATTACHED TO THE STENT. IT COULD NOT BE CONFIRMED HOW THE STENT CAME TO BE PARTIALLY DEPLOYED. A PHOTOGRAPH WAS PROVIDED BY THE CUSTOMER DEPICTING THE DEVICE WITH THE STENT PARTIALLY DEPLOYED AND FM PRESENT ON THE DISTAL END OF THE STENT. INVESTIGATION CONCLUSION: BOSTON SCIENTIFIC CONCLUDES THE MOST PROBABLE ROOT CAUSE AS NO PROBLEM DETECTED BASED ON NO DAMAGE OR DEFORMATION TO THE STENT WAS IDENTIFIED DURING ANALYSIS. THE PAIN, VESSEL TRAUMA AND SERIOUS INJURY/ ILLNESS/ IMPAIRMENT WERE REPORTED TO HAVE OCCURRED DUE TO THE SERIES OF PROCEDURAL EVENTS ENDURED BY THE PATIENT MOST PROBABLE WHEN THE VESSEL'S INTIMA WAS TORN.

Description of Event or Problem

IT WAS REPORTED THAT STENT DAMAGE OCCURRED CAUSING PAIN AND VESSEL TRAUMA. THE TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN. A 14X90/9FR UNI PLUS 75CM WALLSTENT UNI STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS FOUND THAT THE TIP OF THE STENT WAS IRREGULAR IN SHAPE AND HAD ABNORMAL PROTRUDES, WHICH CAUSED SEVERE PAIN TO THE PATIENT. AFTER REMOVAL, IT WAS NOTED THAT THE VESSEL'S INTIMA HAD BEEN TORN AND DAMAGED, AND IT HAD BECOME ATTACHED TO THE STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT CONDITION WAS STABLE FOLLOWING THE PROCEDURE.

Additional Manufacturer Narrative

E1: INITIAL REPORTER PHONE: (B)(6). GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.