BEUDAMED
    FDA Adverse Event Summary report: N

    ANCURE ENDOGRAFT

    MDR report key: 1200414 · Received September 26, 2008

    Report

    Report Number
    2954310-2008-81669
    Date Received
    September 26, 2008
    Date of Event
    September 1, 2006
    Report Date
    September 25, 2008
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT THE PATIENT IMPLANTED WITH THIS ENDOGRAFT UNDERWENT OPEN REPAIR DUE TO GROWTH OF THE ANEURYSMAL SAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCURE ENDOGRAFT GRAFT MIH GUIDANT ENDOVASCULAR SOLUTIONS 204241312-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention