BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOLOGIX POWERLINK SYSTEM WITH INTUITRAK DELIVERY SYSTEM

    MDR report key: 2010462 · Received February 24, 2011

    Report

    Report Number
    2010462
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR, THE STENT SHEATH THAT WAS ABOUT TO BE DEPLOYED BROKE AWAY FROM THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOLOGIX POWERLINK SYSTEM WITH INTUITRAK DELIVERY SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH ENDOLOGIX 25-25-115RL F00302

    Patients

    Seq Age Sex Outcome Treatment
    1 *