BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2122983 · Received June 10, 2011

    Report

    Report Number
    2953161-2011-00136
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 10, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PXT WAS LANDED SHORT OF THE PREFERRED LANDING ZONE BUT IT WAS FINE. FINAL ANGIOGRAPHY REVEALED NO SIGN OF ENDOLEAK. ON (B)(6) 2011, CT SCAN REVEALED DEVICE MIGRATION OF APPROXIMATELY 3-5MM. THE PATIENT DEVELOPED AN ENDOLEAK POST PROCEDURE, CAUSE UNKNOWN. THE PHYSICIAN RE-INTERVENED AND IMPLANTED TWO AORTIC CUFFS PROXIMALLY AND ONE OF THE TWO WAS USED AS A BRIDGE FOR OVERLAP. FINAL ANGIOGRAPHY REVEALED NO ENDOLEAK AND NO SIGN OF ANEURYSM ENLARGEMENT.

    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 7296177

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R