BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    MDR report key: 1991093 · Received February 11, 2011

    Report

    Report Number
    2954310-2011-81792
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    November 1, 2000
    Report Date
    January 13, 2011
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANCURE ENDOGRAFT REMAINS IMPLANTED. AS NO FURTHER INFO CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFO BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (FORMERLY GUIDANT) RECEIVED INFO THAT POST IMPLANT, THIS PATIENT PRESENTED WITH CLAUDICATIONS AND A TYPE FOUR ENDOLEAK WAS DISCOVERED. EMBOLIZATION OF THE BILATERAL ILIOLUMBAR BRANCH FEEDERS WAS PERFORMED TO RESOLVE THE LEAK. POST PROCEDURE, NO PT SYMPTOMS WERE REPORTED. THE ANCURE ENDOGRAFT REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT) GRAFT MIH GUIDANT ENDOVASCULAR SOLUTIONS 13442

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R