BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3221768 · Received July 11, 2013

    Report

    Report Number
    2031527-2013-00154
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 17 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND TWO INFRARENAL AORTIC EXTENSIONS, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN REVEALED A TYPE III ENDOLEAK OF A BIFURCATED DEVICE. REPORTEDLY, THE PHYSICIAN IDENTIFIED A PROXIMAL TYPE I ENDOLEAK DURING A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN (APPROXIMATELY 9 MONTHS), WHICH WAS ORIGINALLY TREATED WITH TWO COMPETITOR¿S STENTS ON EACH SIDE OF THE VESSEL AND AN ADDITIONAL INFRARENAL AORTIC EXTENSION. THE PHYSICIAN ALSO ELECTED TO PLACE A SUPRARENAL AORTIC EXTENSION TO ENSURE A GOOD SEAL. HOWEVER, APPROXIMATELY 9 MONTHS LATER, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN IDENTIFIED A TYPE III ENDOLEAK OF A BIFURCATED DEVICE. THE PATIENT WAS TREATED WITH AN ADDITIONAL INFRARENAL AORTIC EXTENSION, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320135 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA28-80/I16-40 W11-3810-029

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention