BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERLINK SYSTEM

    MDR report key: 694159 · Received March 30, 2006

    Report

    Report Number
    2031527-2006-02005
    Event Type
    Other
    Date Received
    March 30, 2006
    Date of Event
    March 10, 2006
    Report Date
    March 17, 2006
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NINE DAYS POST-IMPLANT, THE PT EXPERIENCED RIGHT ILIAC OCCLUSION AND UNDERWENT FEM-FEM PYPASS, WHICH RESOLVED THE OCCULSION. PHYSICIAN CONSIDERS EVENT PROCEDURE RELATED; NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-155BL W05-0910

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention