BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    MDR report key: 1910411 · Received November 18, 2010

    Report

    Report Number
    2954310-2010-81790
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    December 1, 2008
    Report Date
    October 19, 2010
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANCURE ENDOGRAFT HAS NOT BEEN RETURNED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (FORMERLY GUIDANT) REC'D INFORMATION THAT AN ENDOLEAK WAS IDENTIFIED AND REQUIRED CONVERSION TO OPEN REPAIR. OPEN CONVERSION WAS SUCCESSFULLY PERFORMED. NO ADDITIONAL ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT) GRAFT MIH GUIDANT ENDOVASCULAR SOLUTIONS 13424

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R