BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERLINK SYSTEM

    MDR report key: 721015 · Received May 26, 2006

    Report

    Report Number
    2031527-2006-00014
    Event Type
    Other
    Date Received
    May 26, 2006
    Date of Event
    May 18, 2006
    Report Date
    May 22, 2006
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED WITH SEVERELY CALCIFIED BILATERAL EXTERNAL ILIACS. THE PHYSICIAN DECIDED TO GO UP ON THE RIGHT SIDE. DURING ADVANCEMENT OF A BIFURCATED (25-16-140BL) DELIEVERY SYSTEM, THE EXTERNAL ILIAC WAS DISSECTED JUST DISTAL TO THE HYPOGASTRICS. THE DEVICE WAS REMOVED. THE PHYSICIAN PLACED A BALLOON EXPANDABLE COVERED STENT AND A WALL GRAFT TO ADDRESS THE VESSEL DISSECTION. THE PHYSICIAN DECIDED TO ATTEMPT TO PLACE THE SAME BIFURCATED ON THE OPPOSITE SIDE AND ENCOUNTERED THE SAME CALCIFICATION PROBLEM. THE PHYSICIAN DECIDED TO REMOVE THE DEVICE. DURING RETRACTION, THE MAIN BODY OF THE STENT GRAFT BEGAN TO DEPLOY, BUT THE PHYSICIAN WAS ABLE TO RETRACT THE ENTIRE DEVICE WITHOUT INCIDENT. THE PHYSICIAN DECIDED TO PLACE A COMPETITOR STENT GRAFT DEVICE IMPLANTED FINE. PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 25-16-140BL W06-0235

    Patients

    Seq Age Sex Outcome Treatment
    1 *