BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II

    MDR report key: 3062653 · Received April 10, 2013

    Report

    Report Number
    3062653
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    AFTER DEPLOYING THE MAIN ENDOVASCULAR ANEURYSM REPAIR COMPONENT, IT WAS VERY CHALLENGING TO REMOVE THE DEVICE. IT COULD HAVE BEEN RELATED TO PATIENT'S DISEASE OR DEVICE FAILURE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?EVAR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149952 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT MIH MEDTRONIC ENDURANT II 2015-01-29

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR NO OTHER THERAPIES