BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6115383 · Received November 19, 2016

    Report

    Report Number
    2031527-2016-00541
    Event Type
    Injury
    Date Received
    November 19, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 21, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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, AN INFRARENAL AORTIC EXTENSION, A SUPRARENAL AORTIC EXTENSION, AND A LIMB STENT GRAFT ON (B)(6) 2012. THE PATIENT CAME IN EMERGENTLY WITH BACK PAIN AND A TYPE 3B ENDOLEAK WAS IDENTIFIED AS WELL AS A TYPE 3A ENDOLEAK WITH COMPLETE COMPONENT SEPARATION BETWEEN THE MAIN BODY AND THE INFRARENAL AORTIC EXTENSION. THE PHYSICIAN PLANS TO RELINE THE PATIENT HOWEVER, THE SECONDARY INTERVENTION HAS NOT BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766347 AFX BIFURCATED MIH ENDOLOGIX INC. BA28-100/I16-55 W11-3345-005

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention INFRARENAL AORTO UNI-ILIAC- (B)(4)| LIMB EXTENSION- (B)(4)| SUPRARENAL AORTA UNI-ILIAC- (B)(4)