BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1491334 · Received October 2, 2009

    Report

    Report Number
    2031527-2009-00123
    Event Type
    Death
    Date Received
    October 2, 2009
    Date of Event
    September 3, 2009
    Report Date
    September 23, 2009
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO FOR PROXIMAL EXTENSION: MODEL NO. 25-25-75L; LOT NO. W09-1786-005; EXPIRATION DATE: 07/01/2012. EVALUATION RESULTS PENDING. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. DEVICE WAS USED OFF-LABEL. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    PT PRESENTED WITH ABDOMINAL ANEURYSM AND DISSECTION. TWO KISSING BALLOONS WERE USED TO PREDILATE THE AORTIC BIFURCATION. THE DUAL LUMEN CATHETER WAS UP AND OVER. A MEIER WIRE WAS INTRODUCED UP INTO THE AORTA. ACCESS AND DEPLOYMENT OF A 25-16-120BL BIFURCATED DEVICE AND A 25-25-75L PROXIMAL EXTENSION WERE UNEVENTFUL. UNDER FLUORO, THE RENALS COULD NOT BE LOCATED. AT THIS POINT, THE PHYSICIAN NOTED THAT THE DEVICES WERE INADVERTENTLY DEPLOYED INTO THE FALSE LUMEN OF THE DISSECTION. THE PT WAS CONVERTED TO OPEN REPAIR, AND A SURGICAL GRAFT WAS SEWN IN. BLOOD FLOW WAS NOT COMPLETELY RESTORED DUE TO THE DISTAL LIMBS AND THE DISSECTION APPEARED TO HAVE PROPAGATED INTO THE THORACIC AORTA. THE PT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR THORACIC EVALUATION AND TREATMENT. PT WAS REPORTED TO HAVE DIED AT THAT HOSPITAL. NO FURTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 25-16-120BL W09-1719-008

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R