BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOGIX GRAFT

    MDR report key: 1263277 · Received December 4, 2008

    Report

    Report Number
    MW5009191
    Event Type
    Injury
    Date Received
    December 4, 2008
    Report Date
    December 4, 2008
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GRAFT TORE A HOLE IN THE ILIAC ARTERY. A SECOND GRAFT WAS USED THAT ALSO TORE A HOLE IN THE ILIAC ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOLOGIX GRAFT NONE MIH ENDOLOGIX 25-16-120BL W08-0199
    2 ENDOLOGIX GRAFT NONE MIH ENDOLOGIX W08-0149

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability