BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1715738 · Received June 10, 2010

    Report

    Report Number
    2031527-2009-00015
    Event Type
    Death
    Date Received
    June 10, 2010
    Date of Event
    February 16, 2009
    Report Date
    June 4, 2010
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY SYSTEM AND STENT GRAFT WERE RETURNED TO ENDOLOGIX; THE STENT GRAFT HAD MULTIPLE GRAFT TEARS AND THE DELIVERY SYSTEM CONTAINED DAMAGE TO THE METAL HYPOTUBE AND TO THE FRONT SHEATH. THE REPORT STATES THAT THE OUTER SHEATH COULD NOT BE PULLED BACK TO EXPOSE THE LIMBS WHICH INDICATES THAT THE PHYSICIAN MAY HAVE ATTEMPTED TO DEPLOY THE STENT GRAFT USING METHOD CONTRARY TO THE IFU. THERE IS NO INDICATION THAT THERE IS A MANUFACTURING ISSUE. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. INADVERTENT PERFORATION OF THE ILIAC ARTERY DURING REMOVAL OF THE DELIVERY SYSTEM.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH SEVERE CALCIFICATION AND MODERATE TORTUOSITY IN THE ILIAC VESSELS. ACCESS WITH A 28-16-140BL BIFURCATED DEVICE WAS DIFFICULT DUE TO CALCIFICATION. DURING AN ATTEMPT TO DEPLOY, THE PHYSICIAN WAS UNABLE TO RETRACT THE WHITE HUB TO THE RED HUB TO EXPOSE THE LIMBS, HAD ATTEMPTED SEVERAL TIMES TO MANIPULATE THE DEVICE, AND STILL NOT SUCCESSFUL. THE DELIVERY SYSTEM WAS REMOVED AND INADVERTENTLY PERFORATED THE ILIAC ARTERY JUST DISTAL TO THE AORTIC BIFURCATION. A SECOND BIFURCATED DEVICE WAS IMMEDIATELY DEPLOYED TO EXCLUDE THE PERFORATION, HOWEVER, THE PATIENT HAD GONE INTO CARDIAC ARREST. THE PHYSICIAN ATTEMPTED TO RESUSCITATE THE PATIENT, HOWEVER UNSUCCESSFUL, AND THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-140BL W08-0216-020

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R