BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 4855104 · Received June 18, 2015

    Report

    Report Number
    2031527-2015-00188
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    June 1, 2015
    Report Date
    May 20, 2015
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. BASED UPON THE CLINICAL EVALUATION, THE TYPE IIIB ENDOLEAK WAS CONFIRMED. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES (NO RELATED ISSUES) OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED NO OTHER UNITS FROM THIS LOT WERE INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING.

    Additional Manufacturer Narrative · 1

    ENDOLOGIX CONTINUES TO INVESTIGATE THE REPORTED EVENT. ENDOLOGIX WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 28 MONTHS POST IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION, THE PATIENT WAS SEEN ROUTINELY FOR FOLLOW UP. A SURVEILLANCE COMPUTED TOMOGRAPHY (CT) SCAN INDICATED THE PATIENT HAD AN ENDOLEAK. THE PATIENT WAS NOT HAVING ANY SYMPTOMS. THE PHYSICIAN DECIDED TO CORRECT THE ENDOLEAK BY IMPLANTING ANOTHER BIFURCATED DEVICE AND ANOTHER SUPRARENAL AORTIC EXTENSION. THE PATIENT WAS REPORTED TO BE DOING WELL POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398291 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA28-100/I16-40 1028671-015

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention