BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 9364847 · Received November 22, 2019

    Report

    Report Number
    2031527-2019-00539
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    October 25, 2019
    Report Date
    October 25, 2019
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION. THESE REPORTED EVENTS WERE FOUND DURING A PUBLICATION REVIEW WHERE THE PATIENT INFORMATION IS ANONYMOUS AND SPECIFIC DEVICE INFORMATION FOR THIS PATIENT IS NOT PROVIDED. AS SUCH, EVENT DETERMINATION, OFF LABEL CONDITIONS, RELATED PATIENT HARMS AND PATIENT DISPOSITION COULD NOT BE INDEPENDENTLY ASSESSED. NO ADDITIONAL INVESTIGATION OF THIS REPORTED EVENT IS PLANNED HOWEVER IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ENDOLOGIX WILL CONTINUE TO MONITOR THIS COMPLAINT AND SIMILAR COMPLAINTS IN THE EVENT FURTHER INVESTIGATION IS NEEDED. INSUFFICIENT DEVICE INFORMATION RECEIVED TO DETERMINE DEVICE ITERATION. DEVICE ITERATION WILL BE PROVIDED IF FURTHER INFORMATION IS RECEIVED. LITERATURE CITATION: DOI: HTTPS://DOI.ORG/10.1016/J.JAMCOLLSURG.2019.08.731.

    Description of Event or Problem · 1

    PUBLISHED ON 25OCT2019, IN THE JOURNAL OF AMERICAN COLLEGE OF SURGEONS, SCIENCE FORUM ABSTRACT 28OCT2019, VOLUME 229, ISSUE 4, SUPPLEMENT 1, OCTOBER 2019, PAGE S334 TITLED "RISK OF REINTERVENTION WITH ENDOLOGIX AFX ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM SYSTEMS IN A INTEGRATED HEALTH CASE SYSTEM." THE PATIENT WAS INITIALLY IMPLANTED WITH THE AFX STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE. A TYPE 1 ENDOLEAK OF UNKNOWN ORIGIN AND AN INTERVENTION WAS PERFORMED ON AN UNKNOWN DATE WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THESE REPORTED EVENTS WERE FOUND DURING A PUBLICATION REVIEW WHERE THE PATIENT INFORMATION IS ANONYMOUS AND SPECIFIC DEVICE INFORMATION FOR THIS PATIENT IS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156208 AFX UNKNOWN MIH ENDOLOGIX, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention