BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX SYSTEM

    MDR report key: 2884189 · Received December 21, 2012

    Report

    Report Number
    2031527-2012-00173
    Event Type
    Death
    Date Received
    December 21, 2012
    Date of Event
    December 1, 2012
    Report Date
    March 7, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY TWO DAY POST-IMPLANT THE PATIENT DIED OF CAUSES THAT ARE CURRENTLY UNKNOWN. REPORTEDLY, FOLLOWING THE SUCCESSFUL IMPLANT OF A BIFURCATED DEVICE, AN INFRARENAL AORTIC EXTENSION, A SUPRARENAL AORTIC EXTENSION AND TWO LIMB EXTENSIONS, ANGIOGRAPHIC IMAGES REVEALED WHAT WAS BELIEVED TO BE BILATERAL TYPE III ENDOLEAKS BETWEEN THE JUNCTIONS OF THE LIMB EXTENSIONS AND THE BIFURCATED DEVICE. THE PHYSICIAN PLACED TWO ADDITIONAL LIMB EXTENSIONS ON THE LEFT SIDE AND ONE ADDITIONAL LIMB EXTENSION ON THE RIGHT SIDE; HOWEVER, AN ENDOLEAK WAS STILL PRESENT ON THE LEFT SIDE AT THE END OF THE PROCEDURE. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT, WHERE REPORTEDLY THE PATIENT DIED TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA28-80/I16-40 1031804-012

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Death