BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOLOGIX ENDOGRAFT

    MDR report key: 1471390 · Received August 14, 2009

    Report

    Report Number
    1471390
    Event Type
    Death
    Date Received
    August 14, 2009
    Date of Event
    August 5, 2009
    Report Date
    August 11, 2009
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT AORTIC ENDOGRAFT IN 2009. PATIENT DEVELOPED ACIDOSIS AND HYPOTENSION. CT PERFORMED THE NEXT DAY, INDICATES ENDOGRAPHT APPEARS TO HAVE MIGRATED WITH POSSIBLE CUT OFF THE BLOOD SUPPLY TO THE RENAL ARTERIES. PATIENT RETURNED TO OR ON THE SAME DAY, FOR MALPOSITIONED AORTIC ENDOGRAFT CAUSING ABDOMINAL VISCERAL ISCHEMIA. THE IMPRESSION IS THAT THE ENDOGRAFT APPEARED TO HAVE MIGRATED UPWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOLOGIX ENDOGRAFT ENDOGRAFT MIH ENDOLOGIX, INC. 28-16-140RL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death ALSO USED BUT NOT IMPLANTED DL-35-90| 16-16-55L| 28-28-75T.