WALLSTENT ENDOPROSTHESIS

Description of Event or Problem

IT WAS REPORTED THAT STENT FAILURE TO DEPLOY AND REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 14X90/9FR UNI PLUS 75CM WALLSTENT UNI STENT SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON REACHING THE LESION SITE, THE PULL ROD WAS RETRACTED TO RELEASE THE STENT, BUT THE STENT FAILED TO DEPLOY. DIFFICULTY WITHDRAWING THE STENT ALONG THE GUIDEWIRE WAS NOTED AND AN EXTERNAL ATTEMPT TO RELEASE THE PULL ROD WHERE IT COULD BE RETRACTED WAS MADE, HOWEVER, THE STENT STILL FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

(B)(6). DEVICE ANALYSIS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS CONTAMINATED. DEVICE HISTORY RECORD REVIEW: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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 THE TIME. RISK REVIEW: A RISK REVIEW PERFORMED FOR THE WALLSTENT UNI CONFIRMED THAT THE EVENT OF DELIVERY SYSTEM DIFFICULT TO REMOVE IS A KNOWN EVENT DEFINED IN THE PRODUCT'S RISK MANAGEMENT DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: THIS INVESTIGATION IS ASSIGNED A CONCLUSION CODE OF ADVERSE EVENT RELATED TO PATIENT CONDITION BASED ON THERE BEING NO REPORTED DEVICE INTERACTION/ DAMAGE OR ISSUE UNTIL DEPLOYMENT WAS ATTEMPTED AT THE OCCLUDED LESION SITE. IT IS MOST PROBABLE THAT THE DEVICE WAS DAMAGED/KINKED WHEN ATTEMPTING TO TREAT THE OCCLUDED LESION, CONTRIBUTING TO THE DEPLOYMENT DIFFICULTY AND DIFFICULTY TO WITHDRAW THE DELIVERY SYSTEM.

Additional Manufacturer Narrative

E1: INITIAL REPORTER PHONE: (B)(6). DEVICE ANALYSIS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS CONTAMINATED. DEVICE HISTORY RECORD REVIEW: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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 THE TIME. RISK REVIEW: A RISK REVIEW PERFORMED FOR THE WALLSTENT UNI CONFIRMED THAT THE EVENT OF DELIVERY SYSTEM DIFFICULT TO REMOVE IS A KNOWN EVENT DEFINED IN THE PRODUCT'S RISK MANAGEMENT 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, THE MOST PROBABLE CAUSE FOR THIS COMPLAINT WAS ADVERSE EVENT RELATED TO PATIENT CONDITION. IT IS MOST PROBABLE THAT THE DEVICE WAS DAMAGED/KINKED WHEN ATTEMPTING TO TREAT THE OCCLUDED LESION, CONTRIBUTING TO THE DEPLOYMENT DIFFICULTY.

Description of Event or Problem

IT WAS REPORTED THAT STENT FAILURE TO DEPLOY AND REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 14X90/9FR UNI PLUS 75CM WALLSTENT UNI STENT SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON REACHING THE LESION SITE, THE PULL ROD WAS RETRACTED TO RELEASE THE STENT, BUT THE STENT FAILED TO DEPLOY. DIFFICULTY WITHDRAWING THE STENT ALONG THE GUIDEWIRE WAS NOTED AND AN EXTERNAL ATTEMPT TO RELEASE THE PULL ROD WHERE IT COULD BE RETRACTED WAS MADE, HOWEVER, THE STENT STILL FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.