BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOLOGIX

    MDR report key: 1404644 · Received June 15, 2009

    Report

    Report Number
    MW5011555
    Event Type
    Malfunction
    Date Received
    June 15, 2009
    Date of Event
    May 20, 2008
    Report Date
    June 15, 2009
    Manufacturer
    AGORA TECHNOLOGIE GMBH
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN ENDOLOGIX AAA STENT GRAFT BECAME LODGED IN THE PT'S RIGHT FEMORAL-ILIAC ARTERY DURING AN ATTEMPTED PERCUTANEOUS INSERTION. UPON ATTEMPTING TO REMOVE THE GRAFT, THE CATHETER COVERING THE STENT GRAFT MATERIAL RIPPED AND DISLODGED. THE STENT GRAFT WAS SUCCESSFULLY REMOVED THE INTACT. PROCEDURE WAS COMPLETED USING A DIFFERENT VENDOR'S AAA STENT GRAFT. THIS WAS THE INITIAL AAA STENT GRAFT PRODUCT ATTEMPTED TO BE USED. DATES OF USE: 2008 - 30 MINUTES. DIAGNOSIS OR REASON FOR USE: PERCUTANEOUS AAA GRAFTING. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOLOGIX AAA POWERLINK SYSTEM MIH AGORA TECHNOLOGIE GMBH 28-16-140BL W07-1672

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR