BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1063389 · Received June 19, 2008

    Report

    Report Number
    2953161-2008-00155
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 14, 2008
    Report Date
    June 19, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. UNPLANNED AORTO UNI-ILIAC PROCEDURE.

    Description of Event or Problem · 1

    AS REPORTED, 2008, THIS PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS AN ABDOMINAL AORTIC ANEURYSM. A TRUNK-IPSILATERAL LEG COMPONENT WAS IMPLANTED. ACCESS TO THE CONTRALATERAL GATE WAS OBSTRUCTED BY A SHELF OF CALCIUM, AND COULD NOT BE CANNULATED. THE PHYSICIAN IMPLANTED A SECOND TRUNK-IPSILATERAL LEG COMPONENT TO RELINE THE FIRST COMPONENT AND PERFORMED A UNPLANNED AORTO UNI-ILIAC PROCEDURE. A FEMORO-FEMORAL BYPASS WAS ALSO PERFORMED. THE PATIENT TOLERATED THE PROCEDURE AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES, INC. WLG325 05780643

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other