BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 2863904 · Received December 10, 2012

    Report

    Report Number
    2031527-2012-00171
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE WAS NOT RETURNED HENCE NO DEVICE EVALUATION WAS PERFORMED. BASED UPON THE REVIEW OF LOT RECORDS, WORK ORDERS AND PRIOR REPORTS NO ISSUES WITH THE LOT WERE NOTED. HOWEVER, CT ANGIO SCAN AND REPORT FOR POST PROCEDURE FOLLOW-UP VISIT AND THE OPERATIVE NOTE FROM THE INDEX PROCEDURE WERE PROVIDED FOR CLINICAL ASSESSMENT BY CLINICAL REPRESENTATIVES. BASED ON THE REVIEW, THE REPORT OF ENDOLEAK TYPE III WAS CONFIRMED. AVAILABLE IMAGING SHOWS ANGULATION IN THE ANEURYSM SAC. THE POTENTIAL ROOT CAUSE MAY BE DUE TO LACK OF OVERLAP BETWEEN THE BIFURCATED DEVICE AND THE AORTIC EXTENSION BUT CANNOT BE CONFIRMED. BASED ON THE REVIEW OF THE EVENT, INFORMATION AVAILABLE, MANUFACTURING RECORDS, AND PREVIOUS COMPLAINTS, THERE IS NO EVIDENCE THAT THIS COMPLAINT IS DUE TO A MANUFACTURING ISSUE. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE, AS IDENTIFIED IN THE PRODUCT LABELING.

    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 ONE MONTH POST-IMPLANT OF A SUPRARENAL AORTIC EXTENSION AND A BIFURCATED DEVICE A TYPE III ENDOLEAK WAS IDENTIFIED ON A COMPUTED TOMOGRAPHY SCAN. THE PATIENT WAS TREATED WITH TWO INFRARENAL AORTIC EXTENSIONS, 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
    1 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A25-25/C95-O20 W11-5531-010

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Required Intervention