BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1587319 · Received January 14, 2010

    Report

    Report Number
    2031527-2009-00169
    Event Type
    Death
    Date Received
    January 14, 2010
    Date of Event
    October 19, 2009
    Report Date
    November 19, 2009
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. PT HAD HISTORY OF CAD; PRESENTED WITH HEAVILY CALCIFIED ILIAC VESSELS.

    Description of Event or Problem · 1

    PT PRESENTED WITH CORONARY ARTERY DISEASE AND AN 8CM AAA AND 7MM ILIACS BILATERALLY WHICH WERE HEAVILY CALCIFIED. IN (B) (6) 2009, AN EVAR ATTEMPT WAS MADE ON THE RIGHT SIDE WITH A 28-16-140BL BIFURCATED DEVICE, HOWEVER, UNSUCCESSFUL. AN ATTEMPT WAS MADE ON THE RIGHT SIDE, AND WAS UNSUCCESSFUL AS WELL. THE DECISION WAS MADE TO CONVERT THE PT TO OPEN REPAIR. ABOUT 30 MINUTES INTO THE PROCEDURE, THE PT WENT INTO CARDIAC ARREST, AND WAS REVIVED. A SURGICAL GRAFT WAS SEWN IN; THE PROCEDURE LASTED APPROX 3 HOURS. WHILE BEING CLOSED, THE PT WENT INTO CARDIAC ARREST AGAIN, AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-140BL W09-2258-002

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R