BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6142270 · Received December 2, 2016

    Report

    Report Number
    2031527-2016-00560
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 3, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. DEVICES REMAIN IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT UNDERWENT AN ANGIOGRAM WHERE A TYPE 2 ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL SUPRARENAL AORTIC EXTENSION AND A NON-ENDOLOGIX DEVICE TO RESOLVE THE ENDOLEAK. FINAL ANGIOGRAM SHOWED A SLIGHT TYPE 2 ENDOLEAK REMAINING. THE PATIENT WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792792 AFX BIFURCATED MIH ENDOLOGIX INC. BA28-90/I16-30 1053243-016

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention SUPRARENAL AORTA UNI-ILIAC- 1204001-026