BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOLOGIX

    MDR report key: 10586007 · Received September 24, 2020

    Report

    Report Number
    MW5096848
    Event Type
    Death
    Date Received
    September 24, 2020
    Date of Event
    September 15, 2020
    Report Date
    September 23, 2020
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    UDI-DI
    00818009015075
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING ENDOVASCULAR AAA REPAIR. ENDOGRAFT WAS TWISTED UPON DEPLOYMENT. CASE WAS CONVERTED TO OPEN AAA REPAIR. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046558 ENDOLOGIX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH ENDOLOGIX, INC. BEA22-40/I13-40 00818009015075

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death| L