BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6077110 · Received November 3, 2016

    Report

    Report Number
    2031527-2016-00518
    Event Type
    Injury
    Date Received
    November 3, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 5, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION, THEY REMAIN IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION ON (B)(6) 2013. A FOLLOW UP COMPUTED TOMOGRAPHY SHOWED A TYPE 3 ENDOLEAK. THERE IS NO REPORT OF A SECONDARY INTERVENTION OR FINAL PATIENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726254 AFX BIFURCATED MIH ENDOLOGIX INC. BA28-80/I20-40 1101244-028

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention SUPRARENAL AORTA UNI-ILIAC- (B)(4)