BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 7731244 · Received July 30, 2018

    Report

    Report Number
    2031527-2018-00621
    Event Type
    Injury
    Date Received
    July 30, 2018
    Date of Event
    June 20, 2018
    Report Date
    July 3, 2018
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED CONFIRMING THAT THIS REPORT IS A DUPLICATE OF EVENT REPORTED PER MANUFACTURING REPORT # 2031527-2018-00623. THEREFORE IN REGARDS TO THIS MANUFACTURING REPORT # 2031527-2018-00621, A COMPLAINT IS NOT WARRANTED. ENDOLOGIX WILL CONTINUE TO INVESTIGATE THE REPORTED EVENT UNDER MANUFACTURING REPORT # 2031527-2018-00623.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AND REMAIN IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION IS OBTAINED AT A LATER TIME THAT IS PERTINENT TO THIS EVENT, A FOLLOW-UP REPORT WILL THEN BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT WAS INITIALLY TREATED WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. THE PHYSICIAN ADDITIONALLY IMPLANTED A CTAG DEVICE (NON-ENDOLOGIX) ON (B)(6) 2013 TO TREAT A TYPE III ENDOLEAK. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, A PERSISTING TYPE III ENDOLEAK WAS DETECTED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN EXCLUDER DEVICE ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573786 AFX UNKNOWN MIH ENDOLOGIX UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention