BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX SYSTEM

    MDR report key: 3243943 · Received July 23, 2013

    Report

    Report Number
    2031527-2013-00169
    Event Type
    Death
    Date Received
    July 23, 2013
    Date of Event
    March 14, 2015
    Report Date
    February 22, 2015
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 23 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, A SUPRARENAL AORTIC EXTENSION, AND THREE LIMB EXTENSIONS THE PATIENT PRESENTED WITH ABDOMINAL AND BACK PAIN. A COMPUTED TOMOGRAPHY SCAN REVEALED A TYPE III ENDOLEAK OF A BIFURCATED DEVICE. REPORTEDLY, THE PHYSICIAN IDENTIFIED A TYPE III ENDOLEAK BETWEEN THE SUPRARENAL AORTIC EXTENSION AND THE BIFURCATED DEVICE DURING A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN (APPROXIMATELY 13 MONTHS), WHICH WAS ORIGINALLY TREATED WITH AN INFRARENAL AORTIC EXTENSION AND AN ADDITIONAL SUPRARENAL AORTIC EXTENSION. HOWEVER, APPROXIMATELY 10 MONTHS LATER, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN IDENTIFIED A TYPE III ENDOLEAK OF THE BIFURCATED DEVICE. THE PATIENT WAS TREATED WITH AN ADDITIONAL BIFURCATED DEVICE, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342635 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A34-34/C100-O20 1044103-010

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Required Intervention| D