BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX SYSTEM

    MDR report key: 3962243 · Received July 28, 2014

    Report

    Report Number
    2031527-2014-00214
    Event Type
    Death
    Date Received
    July 28, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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; THEREFORE, IT WAS NOT AVAILABLE FOR ANALYSIS. THERE WERE NO MEDICAL RECORDS AND SUBOPTIMAL IMAGING STUDIES WERE PROVIDED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE WITH THIS IMPRESSION: THE NON-OCCLUSIVE THROMBUS IN THE BIFURCATED MAIN BODY AND AORTIC EXTENSION WAS SUBSTANTIATED. THERE WERE NO IMAGES OF THE REPORTED COMPLETE OCCLUSION. THE REPORT OF CONVERSION AND DEATH COULD NOT BE SUBSTANTIATED BY MEDICAL RECORDS OR IMAGING STUDIES. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO RELATED ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED ALL UNITS WERE CONSUMED AND NO OTHER UNITS WERE INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. ALTHOUGH NOT CONFIRMED, THE REPORTED POSSIBLE SYSTEMIC THROMBOPHILIA MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 3.5 MONTHS POST IMPLANT OF A BIFURCATED DEVICE, A SUPRARENAL AORTIC EXTENSION AND TWO LIMB EXTENSIONS, THROMBUS WAS IDENTIFIED IN THE LUMEN OF THE STENT GRAFT. THE PATIENT WAS BEING MONITORED. THE PATIENT WAS BROUGHT BACK TO THE OR EMERGENTLY ON THE WEEKEND OF (B)(6) WITH A COMPLETELY OCCLUDED GRAFT. A THROMBECTOMY WAS PERFORMED AND THE PATIENT WAS REVISED WITH AN AORTA-UNI DEVICE TO THE LEFT COMMON ARTERY. THE PATIENT DID NOT DO WELL AND PASSED AWAY ON (B)(6). PT UNDERLYING/PRE-EXISTING CONDITIONS: POSSIBLE UNDERLYING THROMBOPHILIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439570 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA28-90/I16-30 W11-3898R-004

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death