BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOLOGIX STENT GRAFT

    MDR report key: 17886282 · Received October 5, 2023

    Report

    Report Number
    MW5146650
    Event Type
    Death
    Date Received
    October 5, 2023
    Date of Event
    October 2, 2023
    Report Date
    October 3, 2023
    Manufacturer
    ENDOLOGIX LLC.
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TYPE III B ENDOLEAK WITH ANEURYSM SAC RUPTURE. PATIENT DIED. FABRIC TEAR IN DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942670 ENDOLOGIX STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH ENDOLOGIX LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Death