BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOGIX AFX

    MDR report key: 8366179 · Received February 21, 2019

    Report

    Report Number
    MW5084272
    Event Type
    Injury
    Date Received
    February 21, 2019
    Date of Event
    January 31, 2019
    Report Date
    February 14, 2019
    Manufacturer
    ENDOLOGIX, INC
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MIGRATION OF EVAR CAUSING TYPE 1 ENDOLEAK AND ENLARGEMENT OF AAA REQUIRING FURTHER INTERVENTION. A (B)(6) YEAR OLD MALE PRESENTED TO ME FOR MIGRATION OF HIS ENDOGRAFT WHICH WAS PLACED IN 2014 AT ANOTHER FACILITY. DUE TO ENLARGEMENT OF HIS AAA (UP TO 6.3CM) TO GRAFT FAILURE, HE REQUIRED EXPLANT OF ENDOGRAFT AND OPEN AAA REPAIR ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153892 ENDOLOGIX AFX SYSTEM, ENDOVASCULAR GRAFT AORTIC ANEURYSM TREATMENT MIH ENDOLOGIX, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention