BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPOSTHESIS

    MDR report key: 1221875 · Received November 4, 2008

    Report

    Report Number
    2017233-2008-00836
    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
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBERS 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 VAIBAHN ENDOPROSTHESIS WAS IMPLANTED IN A PT WITH SEVERE SFA OCCLUSIVE DISEASE. THE DEVICE THROMBOSED IN THE FIRST MONTH POST IMPLANT. THE PT REC'D THROMBOLYTIC THERAPY AND A THROMBECTOMY. THE DEVICE EVENTUALLY OCCLUDED AGAIN, AND AN OPEN SURGICAL PROCEDURE WAS PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention