BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1760456 · Received July 14, 2010

    Report

    Report Number
    2953161-2010-00137
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    December 17, 2009
    Report Date
    July 13, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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.

    Description of Event or Problem · 1

    ON (B) (6) 2009, THIS PATIENT PRESENTED FOR ABDOMINAL AORTIC ANEURYSM REPAIR. INTRA-OPERATIVELY, THE PATIENT WAS NOTED TO HAVE A VERY SHORT PROXIMAL NECK WITH SEVERE ANGULATION. PIGTAIL ANGIOGRAM DEMONSTRATED SEVERE RIGHT RENAL ARTERY STENOSIS. NO EVIDENCE OF ACTIVE RUPTURE WAS FOUND. A COOK 36/111 WAS DEPLOYED IN THE AORTA. NEXT A GORE EXCLUDER AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT WAS IMPLANTED IN THE LEFT ILIAC. AN ADDITIONAL COOK VENOUS LIMB WAS IMPLANTED IN THE RIGHT ILIAC. COMPLETION ANGIOGRAM REVEALED A PERSISTENT SMALL PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO CONVERT THE PATIENT TO OPEN REPAIR NOW THAT HE WAS HEMODYNAMICALLY STABLE. ALL THE DEVICES WERE REMOVED AND A BIFURCATED GRAFT (MANUFACTURER UNKNOWN) WAS SEWN IN. THE PATIENT TOLERATED THE PROCEDURE. APPROXIMATE BLOOD LOSS WAS 1400ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES WLG325 7007150

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| O