BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3875144 · Received October 24, 2013

    Report

    Report Number
    2031527-2013-00261
    Event Type
    Injury
    Date Received
    October 24, 2013
    Date of Event
    September 26, 2013
    Report Date
    September 26, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROX 2 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND AN INFRARENAL AORTIC EXTENSION, A TYPE II ENDOLEAK AND POSSIBLY A PROXIMAL TYPE I ENDOLEAK WERE IDENTIFIED ON A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN. REPORTEDLY, THE ANEURYSM SAC WAS SHRINKING AND THE PT WAS ASYMPTOMATIC; HOWEVER, THE PHYSICIAN ELECTED TO TREAT THE PT WITH AN ADDITIONAL SUPRARENAL AORTIC EXTENSION. REPEAT CT SHOWED GOOD SEAL AND THE TYPE II ENDOLEAK SEEMED BETTER. THE PHYSICIAN ELECTED TO MONITOR THE PT FOR THE NEXT 6 MONTHS AND DETERMINE A COURSE OF ACTION AT THAT POINT. IT WAS REPORTED THAT THE PT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547355 AFX SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT, PRODUCT CODE: MIH MIH ENDOLOGIX, INC. A34-34/C100 1026653-008

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention