BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3051584 · Received April 10, 2013

    Report

    Report Number
    2031527-2013-00085
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT, HENCE DEVICE EVALUATION COULD NOT BE PERFORMED; HOWEVER, THE REVIEW OF THE MEDICAL RECORDS, PERFORMED BY A CLINICAL REPRESENTATIVE CONFIRM THE REPORTED ENDOLEAK EVENT. BASED UPON THE INVESTIGATIONAL FINDINGS, THE CAUSE OF THE REPORTED ENDOLEAK COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, PATIENT ANATOMY MAY HAVE BEEN A FACTOR. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 6 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL EXTENSION, A PROXIMAL TYPE I ENDOLEAK WAS IDENTIFIED ON A COMPUTED TOMOGRAPHY SCAN. THE PATIENT WAS TREATED WITH ADDITIONAL SUPRARENAL AORTIC EXTENSION, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152012 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A34-34/C80-O20 1041865-007

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention