BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6028852 · Received October 13, 2016

    Report

    Report Number
    2031527-2016-00479
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    August 1, 2016
    Report Date
    September 15, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINICAL ASSESSMENT WAS BASED ON PATIENT MEDICAL RECORDS AND NO PATIENT IMAGES. AT THE COMPLETION OF THE CLINICAL EVALUATION, BASED ON THE INFORMATION RECEIVED THE FOLLOWING WERE CONFIRMED: ENDOLEAK TYPE IIIA OF THE RIGHT COMMON ILIAC ARTERY LIMB EXTENSION, AND A PERSISTENT LEFT SIDE TYPE II ENDOLEAK - ILIO-LUMBAR ARTERY. A MANUFACTURING OR DESIGN ISSUE HAS NOT BEEN IDENTIFIED OR SUSPECTED BASED ON THE EVALUATION OF THE REPORTED EVENT. THE DEVICES REMAIN IMPLANTED, THEREFORE NO EVALUATION PERFORMED. BASED ON THE INFORMATION AVAILABLE THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN.

    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, A SUPRARENAL AORTIC EXTENSION AND A LIMB STENT GRAFT ON (B)(6) 2013. IN (B)(6) 2016 THE PATIENT CAME IN FOR A FOLLOW UP AND THE ULTRA SOUND SHOWED A FILLING DEFECT AND POTENTIAL ENDOLEAK. THE PHYSICIAN COMPLETED AN ANGIOGRAM WHICH CONFIRMED A TYPE 3A ENDOLEAK WITH COMPONENT SEPARATION BETWEEN THE MAIN BODY AND THE LIMB EXTENSION. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL LIMB STENT GRAFT TO SEAL THE ENDOLEAK. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680028 AFX BIFURCATED MIH ENDOLOGIX INC. BA22-70/I20-30 1080679-018

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention LIMB- (B)(4)| SUPRARENAL AORTA UNI-ILIAC- (B)(4)