BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2833023 · Received November 2, 2012

    Report

    Report Number
    2953161-2012-00194
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON AN UNK DATE IN 2006, THIS PT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. DURING FOLLOW UP COMPUTED TOMOGRAPHY, IT APPEARED THAT THE ANEURYSM SAC MAY HAVE ENLARGED, ALONG WITH A TYPE II ENDOLEAK EMANATING FROM LUMBAR ARTERIES AND THE INFERIOR MESENTERIC ARTERY AND A POSSIBLE CONTAINED RUPTURE OF THE ANEURYSM SAC. ON (B)(6) 2012, AN INTERVENTION WAS PERFORMED WHEREBY THE ANEURYSM SAC WAS OPENED AND LIGATION OF LUMBAR ARTERIES AND THE INFERIOR MESENTERIC ARTERY WAS PERFORMED. THE GORE EXCLUDER DEVICE WAS WELL POSITIONED WITH NO OTHER EVIDENCE OF LEAK.

    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 04131584

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R