BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3013890 · Received March 20, 2013

    Report

    Report Number
    2031527-2013-00067
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 INFORMATION BECOMES AVAILABLE. (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE WAS NOT RETURNED HENCE NO DEVICE EVALUATION WAS PERFORMED. HOWEVER, MEDICAL RECORDS AND CT SCANS WERE REVIEWED BY CLINICAL REPRESENTATIVE INDICATING THAT THE PROBABLE CASE OF THE TYPE 1B ENDOLEAK WAS THE INABILITY OF THE DEVICE TO MAINTAIN AN ADEQUATE SEAL AT THE DISTAL SEGMENT OF THE RT LIMB. REVIEW OF LOT RECORDS, WORK ORDERS, AND PRIOR REPORTS NO ISSUES WITH THE LOT WERE NOTED. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE, AS IDENTIFIED IN THE PRODUCT LABELING. BASED UPON THE INVESTIGATION FINDINGS, A DEFINITE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND THREE LIMB EXTENSIONS, ENDOLEAK TYPE I WAS NOTED ON THE DISTAL END OF THE RIGHT LIMB EXTENSION. THE PATIENT WAS TREATED WITH AN ADDITIONAL LIMB EXTENSION, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115735 AFX SYSTEM LIMB EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. I20-13/C88F SA 1040024-019

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention