BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3855074 · Received June 9, 2014

    Report

    Report Number
    2031527-2014-00173
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. DEVICE REMAINS IMPLANTED IN PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT, HENCE DEVICE EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS OR IMAGES WERE NOT PROVIDED FOR CLINICAL ASSESSMENT; THEREFORE, A THOROUGH CLINICAL INVESTIGATION OF THE MEDICAL RECORDS WAS NOT POSSIBLE AND A CAUSE COULD NOT BE DETERMINED. ENDOLEAKS ARE A KNOWN INHERENT RISK OF THE PROCEDURE. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED THAT NO OTHER UNITS FROM THE SAME LOT HAVE BEEN INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. CORRECTED DATA: COMMON DEVICE NAME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 15 DAYS POST IMPLANT OF A BIFURCATED DEVICE, TWO INFRARENAL AND ONE SUPRARENAL AORTIC EXTENSIONS, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN REVEALED A PROXIMAL ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL INFRARENAL AORTIC EXTENSION, WHICH RESOLVED THE ENDOLEAK. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335629 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT, PRODUCT CODE:MIH MIH ENDOLOGIX, INC. A34-34/C80-O20V 1203084-019

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention