BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 1221876 · Received November 4, 2008

    Report

    Report Number
    2017233-2008-00834
    Event Type
    Injury
    Date Received
    November 4, 2008
    Report Date
    November 4, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT NUMBER WAS NOT REPORTED FOR THIS EVENT, CONSEQUENTLY, A REVIEW OF THE MANUFACTURING PAPERWORK COULD NOT BE PERFORMED. ATTEMPTS TO GAIN ADDITIONAL INFO REGARDING THE DEVICE THROMBOSIS WERE UNSUCCESSFUL. NO FURTHER INFO IS AVAILABLE.

    Description of Event or Problem · 1

    DURING REVIEW OF A PUBLISHED ARTICLE ("PERCUTANEOUS VIABAHN-ASSISTED SUBINTIMAL RECANALIZATION FOR SEVERE SUPERFICIAL FEMORAL ARTERY OCCLUSIVE DISEASE" JOURNAL OF VASCULAR INTERVENTIONAL RADIOLOGY 2008; 19:493-498, AUTHORS-MICHAEL J. VERTA, MD, JOSEPH R. SCHNEIDER, MD PHD, MARC J. ALONZO, MD, AND DAVID HAHN, MD), A GORE VIABAHN ENDOPROSTHESIS WAS IMPLANTED FOR THE TREATMENT OF A SFA OCCLUSION. THE PT EXPERIENCED AN OCCLUSION 12 HOURS POST IMPLANT BUT DID NOT SEEK MEDICAL ATTENTION UNTIL 24 HOURS LATER. THE ARTICLE REPORTS THAT THE OCCLUSION MOST LIKELY OCCURRED BECAUSE THE PT HAD BEEN TAKEN OFF HIS COUMADIN FOR THE PROCEDURE AND HE FAILED TO TAKE HIS BRIDGE THERAPY. THE ANATOMICAL PATENCY WAS RESTORED BY A SURGICAL THROMBECTOMY BUT THE EXTENT OF ISCHEMIC MUSCLE DESTRUCTION WAS SUCH THAT LIMB AMPUTATION WAS PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1