BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2062665 · Received April 11, 2011

    Report

    Report Number
    2017233-2011-00182
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    January 31, 2011
    Report Date
    April 11, 2011
    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

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE MANUFACTURING PAPERWORK WILL BE CONDUCTED.

    Description of Event or Problem · 1

    ON (B)(6), 2011, A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING THE C3 DELIVERY SYSTEM WAS IMPLANTED. ON AN UNK DATE, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING THE C3 DELIVERY SYSTEM DEVICE WAS IMPLANTED AT THE RENAL ARTERY AND THE RIGHT RENAL ARTERY WAS PARTIALLY OCCLUDED. IT WAS REPORTED TO GORE THAT THE PT TOLERATED THE PROCEDURE. NO SEQUELA FROM THE OCCLUSION WAS REPORTED TO GORE. FURTHER INFORMATION WAS REQUESTED.

    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 WLG425 8257930

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| O