BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1130223 · Received August 19, 2008

    Report

    Report Number
    2031527-2008-00044
    Event Type
    Death
    Date Received
    August 19, 2008
    Date of Event
    July 28, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. THE DEVICE MET SPECS PRIOR TO RELEASE. DUE TO LACK OF INFO, NO CONCLUSION CAN BE DRAWN AT THIS TIME. OP NOTE AND DISCHARGE SUMMARY HAVE BEEN REQUESTED.

    Description of Event or Problem · 1

    A BIFURCATED DEVICE WAS ADVANCED OVER A MEIER WIRE INTO POSITION. THERE SEEMED TO BE A WIRE WRAP, AND THE DEVICE WAS MOVED A FEW TIMES TO ALLEVIATE THIS. IT WAS THOUGHT THAT THERE WAS NO WIRE WRAP, AND THE LIMBS WERE SEPARATED. A WIRE WRAP WAS NOTED. THE DEVICE WAS ADVANCED AND RETRACTED 3-4 TIMES, THE WIRE WRAP ALLEVIATED, AND THE MAIN BODY DEPLOYED. A PROXIMAL EXTENSION WAS DEPLOYED, AND A COMPLETION AORTOGRAM WAS DONE. WHILE IN THE ICU, APPROX 30-45 MINS AFTER CLOSE OF THE PROCEDURE, THE PT HAD A "COLD LEG". AN INFUSION CATHETER WAS USED IN AN ATTEMPT TO DECLOT THE LEG. THE PT DIED IN 2008. CAUSE OF DEATH: RESPIRATORY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 25-16-120BL W07-1610

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R