BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1576640 · Received January 8, 2010

    Report

    Report Number
    2031527-2009-00196
    Event Type
    Death
    Date Received
    January 8, 2010
    Date of Event
    December 8, 2009
    Report Date
    January 7, 2010
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. PT PRESENTED WITH RENAL FAILURE AND CHF PRIOR TO PROCEDURE. CAUSE OF DEATH IS UNK, THEREFORE, NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    PT PRESENTED WITH RENAL FAILURE AND CONGESTIVE HEART FAILURE. IN 2009, ACCESS AND DEPLOYMENT OF A 25-16-120BL BIFURCATED DEVICE AND TWO 25-25-75L PROXIMAL EXTENSIONS WERE UNEVENTFUL. IN RECOVERY, THE PT'S BP FLUCTUATED AND WAS MONITORED OVERNIGHT. THE NEXT DAY, THE PT'S POTASSIUM LEVELS WERE ELEVATED, AND THE PT WAS TRANSFERRED TO THE ICU, WHERE HE LATER DIED. CAUSE OF DEATH IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 25-16-120BL W09-3129-006

    Patients

    Seq Age Sex Outcome Treatment
    1 Death