BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3082921 · Received April 22, 2013

    Report

    Report Number
    2953161-2013-00055
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD EXTREME TORTUOSITY IN THE AORTIC NECK AND ILIAC ARTERIES. IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN HAD TO CONSTRAIN AND REPOSITION THE TRUNK-IPSILATERAL LEG COMPONENT IN ORDER TO CANULATE THE GATE. THE CONTRALATERAL LEG COMPONENT WAS DEPLOYED AND THE PHYSICIAN NOTICED A KINK IN THE LEFT COMMON ILIAC LIMB OF THE DEVICE. THE PHYSICIAN BALLOONED IN SEVERAL AREAS AND SMOOTHED OUT THE KINK. THE PATIENT TOLERATED THE PROCEDURE. APPROXIMATELY FOUR HOURS POST PROCEDURE, THE PHYSICIAN CONFIRMED A LOSS OF PULSE IN THE LEFT LIMB OF THE PATIENT. THE PHYSICIAN REINTERVENED AND DISCOVERED THE CONTRALATERAL LEG COMPONENT HAD RE-KINKED. HE IMPLANTED TWO STINTS INSIDE THE KINKED CONTRALATERAL LEG COMPONENT. THIS RESOLVED THE ISSUE. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172149 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 11085502

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention