BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOGIX AFX

    MDR report key: 5949146 · Received September 11, 2016

    Report

    Report Number
    MW5064731
    Event Type
    Injury
    Date Received
    September 11, 2016
    Date of Event
    August 11, 2016
    Report Date
    September 11, 2016
    Manufacturer
    ENGOLOGIX
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TYPE 3 ENDOLEAK FOLLOWING DEVICE PULLING APART 3 YEARS POST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593695 ENDOLOGIX AFX ENDOLOGIX AFX (EVAR) DYB ENGOLOGIX AFX

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening