BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1509762 · Received October 14, 2009

    Report

    Report Number
    2031527-2009-00127
    Event Type
    Injury
    Date Received
    October 14, 2009
    Date of Event
    September 16, 2009
    Report Date
    October 13, 2009
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GROSS EVAL OF THE EXPLANTED STENT GRAFTS CONFIRMED THROMBUS ON THE PROXIMAL EXTENSION CAUSING A PARTIAL COMPRESSION AND SEPARATION BETWEEN THE PROXIMAL EXTENSION AND BIFURCATED MAIN BODY. THERE WERE NO TEARS IN THE GRAFT MATERIAL AND NO FRACTURES OR DISCONNECTS IN THE STENT WIRES. METHOD - REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. RESULTS & CONCLUSIONS - THIS IS AN UNUSUAL EVENT WITH INADEQUATE INFO, NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    PT HAD IMPLANT OF A BIFURCATED DEVICE AND A PROXIMAL CUFF IN 2009. APPROX 5 MONTHS POST IMPLANT, THE PT PRESENTED WITH BUTT CLAUDICATION. IMAGES REVEALED THROMBUS BETWEEN THE CUFF AND BIFURCATED MAIN BODY, CAUSING THE CUFF TO BE COMPRESSED. THE DEVICES WERE EXPLANTED, AND THE PT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL PROXIMAL EXTENSION MIH ENDOLOGIX, INC. 25-25-55L W08-3017-016

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention