BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOLOGIX BIFURCATED STENT GRAFT/SHEATH

    MDR report key: 2472897 · Received February 22, 2012

    Report

    Report Number
    2472897
    Event Type
    Death
    Date Received
    February 22, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 20, 2012
    Manufacturer
    ENDOLOGIX
    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

    DURING AN ATTEMPTED ENDOVASCULAR REPAIR OF A INFRARENAL AORTIC ANEURYSM, THE PROCEDURALIST WAS UNABLE TO DEPLOY THE BIFURCATING ENDOLOGIX DEVICE ..."BECAUSE PROBABLY THE DEVICE WAS WRAPPED WITHIN THE SHEATH ITSELF AND WOULD NOT OPEN." ..."MULTIPLE ATTEMPTS WITH MULTIPLE DIFFERENT WIRE TECHNIQUES, ETC., TRYING TO OPEN THE DEVICE AND THE DEVICE COULD NOT BE OPENED. THEN, THE STRING THAT ATTACHES THE GRAFT ITSELF BROKE AND SO THERE WAS NO WAY TO RETRIEVE IT"... THE PT WAS TAKEN FOR OPEN SURGICAL REPAIR OF THE ANEURYSM AND RETRIEVAL OF THE DEVICE. THE OPERATIVE REPORT INDICATES ..."I OPENED THE ANEURYSM...AND THERE WAS A LARGE AMOUNT OF FRESH THROMBUS AS WELL AS OLD THROMBOSIS WHICH APPEARED TO BE CHEWED UP WITH THE DEVICE." THE DEVICE WAS EXPLANTED DURING THE PROCEDURE. PT TRANSFERRED TO AICU FOLLOWING THE PROCEDURE BUT EXPIRED LATER THAT EVENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOLOGIX BIFURCATED STENT GRAFT/SHEATH NONE MIH ENDOLOGIX

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death