BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6157179 · Received December 9, 2016

    Report

    Report Number
    2031527-2016-00577
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 8, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    UDI-DI
    00818009013637
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2016 WITH A BIFURCATED STENT AND SUPRARENAL AORTIC EXTENSION. FOLLOWING THE INITIAL PROCEDURE THE PHYSICIAN IDENTIFIED A TYPE 1A ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN NON-ENDOLOGIX STENT TO SEAL THE ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811097 AFX SUPRARENAL AORTA UNI-ILIAC MIH ENDOLOGIX INC. A28-28/C95-O20 V 1441533-013 00818009013637

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention BIFURCATED- (B)(4)