BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK BIFURCATED SYSTEM

    MDR report key: 645848 · Received November 11, 2005

    Report

    Report Number
    2031627-2005-00022
    Event Type
    Injury
    Date Received
    November 11, 2005
    Date of Event
    October 10, 2005
    Report Date
    October 11, 2005
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    20 HOURS AFTER STENT GRAFT IMPLANT, PROXIMAL PORTION OF GRAFT BECAME OCCLUDED. WIRE ACCESS WAS GAINED, BERENSTEIN CATHETER USED TO OPEN, AND A CUFF WAS IMPLANTED. THE STENT GRAFT WAS PLACED WITHIN A 10-YEAR OLD VASCULAR CUFF. THE PROXIMAL PORTION OF THE CUFF APPEARED COMPRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK BIFURCATED SYSTEM INFRARENAL STENT GRAFT MIH ENDOLOGIX, INC. 26-16-140BL W05-0914

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention