BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 1211507 · Received October 22, 2008

    Report

    Report Number
    2017233-2008-00779
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 22, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED PENDING THE RETURN OF THE DEVICE. A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSION - THE INVESTIGATION IS IN PROCESS PENDING THE RECEIPT AND ANALYSIS OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH A LEFT ILIAC ARTERY OCCLUSION, LEFT RENAL ARTERY STENOSIS AND SEVERE DISEASE OF THE PROXIMAL PROFUNDA FEMORIS, SFA, AND THE COMMON FEMORAL ARTERY. THE PATIENT UNDERWENT AN ANGIOPLASTY AND STENTING TO THE LEFT RENAL ARTERY STENOSIS USING A 6X15 NON GORE STENT. A GORE VIABAHN ENDOPROSTHESIS WAS DEPLOYED INTO THE RIGHT PROXIMAL COMMON ILIAC ARTERY EXTENDING INTO THE DISTAL ABDOMINAL AORTA. REPORTEDLY, THE DEVICE DEPLOYMENT LINE BROKE AFTER THE PROXIMAL HALF OF THE DEVICE DEPLOYED. ATTEMPTS RETRIEVE THE END OF THE DEPLOYMENT LINE AND COMPLETE DEPLOYMENT WERE UNSUCCESSFUL. AN ADDITIONAL ATTEMPT TO RETRIEVE THE DEVICE RESULTED IN THE DESTRUCTION OF THE RIGHT COMMON ILIAC ARTERY, AS WELL AS THE RIGHT INTERNAL ILIAC ARTERY. THE RIGHT PROXIMAL COMMON ILIAC AND DISTAL ABDOMINAL AORTA STILL SHOWED SOME EXTRAVASATION. THE VESSELS WERE SUCCESSFULLY COILED WITH MULTIPLE NESTER COILS. THE LEFT COMMON FEMORAL ARTERY AND PROXIMAL LEFT COMMON ILIAC ARTERY WERE SUCCESSFULLY TREATED WITH TWO VIABAHN DEVICES. THE PATIENT LATER DEVELOPED RENAL FAILURE AND REQUIRED A BILATERAL BELOW THE KNEE FASCIOTOMY. THE PHYSICIAN FELT THE RENAL FAILURE MIGHT HAVE BEEN DUE PROLONGED ISCHEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE VIABAHN ENDOPROSTHESIS NONE NIP W.L. GORE & ASSOCIATES WLG335 06011306

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention