BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2122977 · Received June 9, 2011

    Report

    Report Number
    2953161-2011-00131
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 8, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6), 2011, THIS PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM AND RIGHT ILIAC ARTERY ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESIS. COMPLETION ANGIOGRAPHY REVEALED THAT ONE LIMB OF THE ILIAC EXTENDER COMPONENTS IMPLANTED WAS KINKED POST IMPLANT. THE ILIAC ARTERY WAS REPORTED TO HAVE A VERY SHARP RIGHT ANGLE TURN DISTAL TO THE ILIAC BIFURCATION. THE PHYSICIAN ELECTED TO PLACE THE PXL THERE REGARDLESS OF PATIENT ANATOMY. THE KINK WAS PRESENT BUT SINCE THERE WAS GOOD BLOOD FLOW AND PEDAL PULSES VERIFIED, THE PHYSICIAN LEFT IT AS IS. LATER THAT EVENING, A FEM FEM BYPASS PROCEDURE WAS PERFORMED BY DR (B)(6). ON (B)(6), 2011, A FOLLOW UP CT REVEALED A CLOTTED LIMB OF ONE OF THE PXL'S THAT WAS KINKED. DR (B)(6) REINTERVENED ON THE PATIENT'S RIGHT SIDE IMPLANTING BARE METAL STENTS (MANUFACTURER UNKNOWN) INSIDE THE KINKED PORTION OF THE DEVICE. THE PHYSICIAN ALSO PERFORMED BALLOON ANGIOPLASTY. THE PATIENT TOLERATED THE PROCEDURE AND THERE WAS GOOD BLOOD FLOW DISTALLY.

    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 8530975

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R (B)(4)