BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERLINK SYSTEM

    MDR report key: 724329 · Received June 9, 2006

    Report

    Report Number
    2031527-2006-00015
    Event Type
    Other
    Date Received
    June 9, 2006
    Date of Event
    May 15, 2006
    Report Date
    June 7, 2006
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 3

    H6. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. H6 UNK AT THIS TIME; INFORMATION PENDING.

    Description of Event or Problem · 3

    AN INFRARENAL BIFURCATED DEVICE (25-16-140BL) AND CUFF (28-28-75L) WERE IMPLANTED ON 5/10/06. IT WAS NOTED THAT THERE WAS SEVERE NECK ANGULATION. DUE TO THE ANGULATION, IT WAS DIFFICULT TO PLACE THE INFRARENAL CUFF, IT WOULD NOT SIT WELL IN THE ANGULATION AND THE CUFF DRIPPED DOWN SLIGHTLY, BUT IMPLANTED FINE. THE PT WAS FINE POST OP. ON 5/15/06, THE DEVICES HAD TO BE EXPLANTED DUE TO THROMBUS CAUSED BY THE PROXIMAL NECK ANGULATION. THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM BIFURCATED INFRARENAL STENT GRAFT MIH ENDOLOGIX, INC. 25-16-140BL W06-0090

    Patients

    Seq Age Sex Outcome Treatment
    3 YR Required Intervention