BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3243939 · Received July 23, 2013

    Report

    Report Number
    2031527-2013-00171
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 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. REMAINS IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND THEREFORE, DEVICE EVALUATION COULD NOT BE PERFORMED. COMPUTED TOMOGRAPHY IMAGING WAS PROVIDED; HOWEVER, DID NOT INCLUDE IMAGES APPLICABLE TO THE EVENT DESCRIPTION; THEREFORE, A CLINICAL ASSESSMENT COULD NOT BE PERFORMED, THUS A CAUSE AND EFFECT COULD NOT BE DETERMINED. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 58 MONTHS POST IMPLANT OF A BIFURCATED DEVICE AND TWO PROXIMAL INFRARENAL AORTIC EXTENSIONS A COMPUTED TOMOGRAPHY SCAN IDENTIFIED A SEPARATION WITH THROMBUS BETWEEN THE BIFURCATED DEVICE AND THE PROXIMAL AORTIC EXTENSION. THE PATIENT WAS TREATED WITH AN ADDITIONAL INFRARENAL AORTIC EXTENSION WHICH SUCCESSFULLY CORRECTED THE SEPARATION. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343432 AFX SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 25-25-55L W07-2252-004

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention