BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 1063454 · Received June 19, 2008

    Report

    Report Number
    2017233-2008-00338
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 26, 2008
    Report Date
    June 19, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES,
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH A LEFT SFA CALCIFIED STENOTIC LESION. PTA WAS PERFORMED THROUGH THE ENTIRE LESION. IMAGES POST PTA SHOWED BETTER FLOW WITH VESSEL STENOSIS WAS STILL PRESENT. A GORE VIABAHN ENDOPROSTHESIS WAS PLACED IN THE DESIRED POSITION. FOLLOWING THE REMOVAL OF THE DELIVERY CATHETER (WITHIN 1-3 MINUTE), NO FLOW THROUGH THE DEVICE COULD BE OBSERVED. A PTA WAS PERFORMED THROUGH THE ENDOPROSTHESIS; HOWEVER, NO FLOW COULD BE OBSERVED THROUGH THE DEVICE. THE PHYSICIAN FELT THE DEVICE MIGHT HAVE THROMBOSED. THE PATIENT WAS SENT TO THE OR WHERE AN UNKNOWN SURGICAL PROCEDURE WAS PERFORMED. THE PATIENT WAS FINE POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE VIABAHN ENDOPROSTHESIS NONE NIP W.L. GORE & ASSOCIATES, WLG335 05779917

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention