BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 2921304 · Received January 17, 2013

    Report

    Report Number
    2031527-2013-00020
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE WAS NOT RETURNED HENCE NO DEVICE EVALUATION WAS PERFORMED. MEDICAL RECORDS WERE REQUESTED BUT THEY WERE DENIED BY THE HOSPITAL. REVIEW OF THE MANUFACTURING RECORDS AND COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE IS NO INDICATION THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE AND ARE IDENTIFIED IN THE PRODUCT LABELING. BASED ON THE INFORMATION REVIEWED, THE CAUSE FOR THE REPORTED ENDOLEAK TYPE III COULD NOT BE DETERMINED.

    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. (B)(4): DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 15 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, AN ILIAC LIMB EXTENSION, AND TWO SUPRARENAL EXTENSIONS (REFER TO MDR REPORT NUMBER 2031527-2013-00021), A TYPE III ENDOLEAK WAS IDENTIFIED ON A FOLLOWED COMPUTED TOMOGRAPHY SCAN BETWEEN THE SUPRARENAL CUFFS. THE PATIENT WAS TREATED WITH AN INFRARENAL AORTIC EXTENSION, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. IT WAS REPORTED THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25806 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A34-34/C80-O20 W11-4081-008

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention