BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOGIX AFX

    MDR report key: 9224823 · Received October 22, 2019

    Report

    Report Number
    MW5090560
    Event Type
    Injury
    Date Received
    October 22, 2019
    Date of Event
    October 19, 2018
    Report Date
    October 19, 2019
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MAJOR FABRIC HOLE IN EVAR ENDOGRAFT MEASURING 3X3 CM REQUIRING EXPLANTATION OF DEVICE DUE TO ANEURYSM SAC ENLARGEMENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011900 ENDOLOGIX AFX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH ENDOLOGIX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening