BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6042394 · Received October 19, 2016

    Report

    Report Number
    2031527-2016-00487
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 20, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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.

    Additional Manufacturer Narrative · 1

    AT THE COMPLETION OF THE CLINICAL EVALUATION, BASED ON THE INFORMATION RECEIVED THE FOLLOWING WERE CONFIRMED; ENDOLEAK TYPE IIIB REPAIRED WITH A MAIN BODY STENT. ADDITIONALLY THERE WAS NO EVIDENCE TO REASONABLY SUPPORT THE FOLLOWING OBSERVATIONS; ENDOLEAK TYPE II OF MULTIPLE PATENT LUMBAR, AND DISTAL SUPRARENAL STENT MOVEMENT. THE CLINICAL ASSESSMENT WAS BASED ON ADEQUATE PATIENT MEDICAL RECORDS, AND ADEQUATE PATIENT IMAGES. BASED ON THE INFORMATION AVAILABLE THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN. CLINICAL FOUND EVIDENCE TO REASONABLY SUGGEST THE FOLLOWING CONTRIBUTING FACTORS TO THE REPORTED EVENT; OFF LABEL, AND PATIENT ANATOMY. FURTHER INVESTIGATION OF THIS COMPLAINT EVENT CAN BE FOUND UNDER: CAPA (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2013 WITH A BIFURCATED STENT AND SUPRARENAL AORTIC EXTENSION. THE PATIENT WAS TRANSFERRED FROM ANOTHER HOSPITAL AND DIAGNOSED WITH A TYPE 3B ENDOLEAK. PATIENT IS IN STABLE CONDITION. SECONDARY HAS BEEN SCHEDULED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION : SECONDARY WAS DONE AS SCHEDULED ON (B)(6) 2016. A BIFURCATED DEVICE WAS USED TO RE-LINE AND RESOLVE 3B ISSUE, AND PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691295 AFX BIFURCATED MIH ENDOLOGIX INC. BA25-110/I20-30 1098686-018

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention