BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOGIX

    MDR report key: 2804255 · Received October 16, 2012

    Report

    Report Number
    MW5027343
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 20, 2012
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING DEPLOYMENT OF STENT, THE TIP OF INTRODUCER OR STENT DEPLOYMENT DEVICE HAD TO BE RETRIEVED BY SNARE. PIECE WAS SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOLOGIX AAA STENT GRAFT MIH ENDOLOGIX I16-16C55F

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention