BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOLOGIX BIFURICATED STENT GRAFT

    MDR report key: 10605689 · Received September 29, 2020

    Report

    Report Number
    MW5096936
    Event Type
    Death
    Date Received
    September 29, 2020
    Date of Event
    September 15, 2020
    Report Date
    September 25, 2020
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) YO FEMALE UNDERWENT INFRARENAL ABDOMINAL AORTIC STENT GRAFT ON (B)(6) 2020. DURING THE PROCEDURE, THE ENDOLOGIX STENT GRAFT MALFUNCTIONED. THE PULL THROUGH WIRE OF THE ENDOLOGIX WAS WRAPPED AROUND THE GRAFT AND WAS IMPOSSIBLE TO STRAIGHTEN OUT THE WIRE TO SEE THE GRAFT IN THE BIFURCATION OF THE OF THE ILIACS. THE STENT WAS CROSSED INSIDE THE ABDOMINAL AORTA AND THE PULL THROUGH WIRE WAS WRAPPED AROUND IT. A DECISION WAS MADE TO ABORT THE STENT GRAFT PLACEMENT. SINCE THE STENT GRAFT THAT WAS PARTIALLY DEPLOYED IN THE AORTA COULD NOT PULLED THE PROCEDURE WAS CONVERTED TO A OPEN OPERATION. POST PROCEDURE, THE PATIENT WAS SENT TO THE SICU. SHE HAD CARDIAC ARREST X 4. EBL = 1.5 L WHICH REQUIRED 7 U PRBC, 4 U FFP, 1 U PLTS. THE PATIENT CONTINUED TO DETERIORATE AND WAS SUBSEQUENTLY WAS PRONOUNCED. IT IS NOT KNOWN WHETHER THIS WAS USER ISSUE OR DEVICE ISSUE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065526 ENDOLOGIX BIFURICATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH ENDOLOGIX, INC. BEA22-40/I13-40 2331732009

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death