BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOLOGIX AFX GRAFT

    MDR report key: 22740079 · Received August 7, 2025

    Report

    Report Number
    MW5174189
    Event Type
    Death
    Date Received
    August 7, 2025
    Date of Event
    August 2, 2025
    Report Date
    August 4, 2025
    Manufacturer
    ENDOLOGIX LLC.
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LEAK WITHIN AFX ENDOGRAFT RESULTING IN PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940519 ENDOLOGIX AFX GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH ENDOLOGIX LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Death