BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 1032836 · Received April 22, 2008

    Report

    Report Number
    2017233-2008-00149
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 18, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A GORE VIABAHN ENDOPROSTHESIS WAS SUCCESSFULLY DEPLOYED FOR THE TREATMENT OF A SFA OCCLUSION. DURING THE DEPLOYMENT OF THE SECOND DEVICE, THE DEPLOYMENT LINE BROKE RESULTING IN PARTIAL DEPLOYMENT OF DEVICE. THE PHYSICIAN CUT DOWN THE DELIVERY CATHETER, RETRIEVED THE END OF THE DEPLOYMENT LINE, AND SUCCESSFULLY COMPLETED THE DEVICE DEPLOYMENT. HOWEVER, THE DEVICE DEPLOYED IN THE EXTERNAL ILIAC ARTERY AND COVERED PROFUNDA ARTERY. THE PATIENT WAS LATER TRANSFERRED TO THE OR, WHERE THE PHYSICIAN SURGICALLY REMOVED THE DEVICE COVERING THE PROFUNDA ARTERY AND REPAIRED THE VESSEL. THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE VIABAHN ENDOPROSTHESIS PERIPHERAL ENDOVASCULAR STENT GRAFT NIP W.L. GORE & ASSOCIATES, INC. WLG335 05246753

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention