BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2233946 · Received August 30, 2011

    Report

    Report Number
    2017233-2011-00446
    Event Type
    Injury
    Date Received
    August 30, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 29, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE PT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DEVICE. THE DEVICE WAS DISPLAYED AT THE DESIRED LOCATION JUST BELOW THE RENAL ARTERIES. AN ANGIOGRAM REVEALED THAT THE PT'S LEFT INTERNAL ILIAC ARTERY WAS UNINTENTIONALLY COVERED. A BALLOON WAS USED TO MOVE THE DISTAL PORTION OF THE IPSILATERAL LEG PROXIMAL ENOUGH TO ALLOW FOR PARTIAL BLOOD FLOW INTO THE LEFT INTERNAL ILIAC ARTERY. THE PROXIMAL PORTION OF THE TRUNK-IPSILATERAL LEG COMPONENT REMAINED AT THE DESIRED LOCATION. THE PT TOLERATED THE PROCEDURE.

    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 8624415

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R THE PT'S MEDICATIONS INCLUDE XANAX| ALEGRA| ASPIRIN| LOVASTATIN| METAPROLOL