BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOGIX VELA

    MDR report key: 17886582 · Received October 5, 2023

    Report

    Report Number
    MW5146667
    Event Type
    Injury
    Date Received
    October 5, 2023
    Date of Event
    August 24, 2023
    Report Date
    October 3, 2023
    Manufacturer
    ENDOLOGIX LLC.
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TYPE 3 ENDOLEAK FROM ENDOLOGIX AAA ENDOGRAFT WITH SAC ENLARGEMENT. KNOWN ISSUE. REPAIRED WITH RELINING WITH A DIFFERENT BRAND. ARTERIAL PHASE ENDOLEAK WITHOUT TYPE 2 SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966760 ENDOLOGIX VELA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH ENDOLOGIX LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention