BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 7451815 · Received April 23, 2018

    Report

    Report Number
    2031527-2018-00378
    Event Type
    Injury
    Date Received
    April 23, 2018
    Date of Event
    February 17, 2017
    Report Date
    April 23, 2018
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES 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

    PER MEDSUN REPORT WITH THE FOLLOWING INFORMATION: TYPE OF DEVICE; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT DEVICE BRAND NAME; AFX DEVICE MANUFACTURER'S NAME; ENDOLOGIX, INC. DATE OF THIS REPORT (MM/DD/YYYY); (B)(6) 2017. DESCRIBE THE EVENT OR PROBLEM; THE PATIENT WAS BROUGHT TO OR (OPERATING ROOM) ON (B)(6) [DEFAULT (B)(6) 2017 PER DATE OF MEDSUN REPORT] FOR RE-OPERATIVE ENDOVASCULAR AORTIC REPAIR (EVAR) WITH A 28_100/16-40 ENDOLOGIX GRAFT, SECONDARY TO THE FAILED ENDOLOGIX GRAFT IMPLANTED ALMOST EXACTLY FOUR (4) YEARS EARLIER [DEFAULT INDEX CASE DATE (B)(6) 2013]. THE RE-OPERATIVE EVAR WAS A SUCCESS AND THE PATIENT WAS DISCHARGED IN GOOD CONDITION. NOTE, THE AAA (ABDOMINAL AORTIC ANEURYSM) DID NOT RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294337 AFX BIFURCATED STENT GRAFT MIH ENDOLOGIX INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention