BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1130453 · Received August 19, 2008

    Report

    Report Number
    2031527-2008-00042
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    July 9, 2007
    Report Date
    July 21, 2008
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS, NO ISSUES WERE NOTED. THE DEVICE MET SPECIFICATIONS PRIOR TO RELEASE. DUE TO LACK OF INFO , NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ACCORDING TO COMPLAINT IN LAWSUIT, AN INFRARENAL BIFURCATED STENT GRAFT WAS USED FOR CORRECTION OF AN ABDOMINAL AORTIC ANEURYSM IN 2007, DURING WHICH A LACERATION OF THE LEFT COMMON FEMORAL ARTERY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-140BL W07-1001-008

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention