BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOLOGIX AFX

    MDR report key: 14622261 · Received June 6, 2022

    Report

    Report Number
    MW5110134
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    May 27, 2022
    Report Date
    June 2, 2022
    Manufacturer
    ENDOLOGIX LLC.
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEVICE FAILURE - KNOWN ISSUE WITH FABRIC TEAR IN THE ENDOLOGIX AFX DEVICE WHICH RESULTED IN A RUPTURE ANEURYSM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318720 ENDOLOGIX AFX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH ENDOLOGIX LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown