BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX SYSTEM

    MDR report key: 3864157 · Received June 10, 2014

    Report

    Report Number
    2031527-2014-00169
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 17, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. PRE-OPERATIVE AND POST-OPERATIVE IMAGING WERE PROVIDED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE. THE REVIEW INDICATES: THE PATIENT'S UNUSUAL REVERSE TAPERED ANEURYSM WITH MID AORTIC, DISSECTED, CALCIFIED INTIMA MIGHT HAVE BEEN A CONTRIBUTORY FACTOR IN THE PRESENCE OF THE PERSISTENT ENDOLEAK. THERE MIGHT HAVE BEEN POSSIBILITY OF A TYPE III-B ENDOLEAK. THERE MIGHT HAVE BEEN EVIDENCE OF A TYPE II ENDOLEAK FROM LEFT HYPOGASTRIC BRANCH AT INDEX PROCEDURE. THE PREVIOUS PERSISTENT ENDOLEAK (TYPE II OR III-B) WAS SUBSTANTIATED ON THE POST STENT CT STUDY, ALONG WITH RIGHT ILIAC STENT NARROWING, BUT NO SEPARATE RIGHT ILIAC ANEURYSM AS PREVIOUSLY IDENTIFIED. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE MONTH POST-IMPLANT OF A BIFURCATED DEVICE, AN ANGIOGRAM AND COMPUTED TOMOGRAPHY (CT) SCAN REVEALED AN UNKNOWN ENDOLEAK. THE PHYSICIAN WAS UNCERTAIN OF THE ORIGIN AND PERFORMED A REPEAT CT SCAN THE FOLLOWING MONTH. THE REPORT INDICATED THAT THE SACCULAR ANEURYSM APPEARED TO EXTEND INTO THE RIGHT ILIAC ARTERY. REVIEW OF THE IMAGING IS NOT CLEAR WHETHER THERE ARE TWO SOURCES OF LEAKS OR IF IT COMES FROM THE LEFT POSTERIOR-LATERAL ASPECT OF THE BIFURCATED DEVICE MAIN BODY. THERE IS A PRONOUNCED PERFUSION OF WHAT SEEMS LIKE ONE OF THE LOW LUMBAR ARTERIES, BUT IT IS A LATE ENHANCEMENT, AFTER THE BLOOD IS ALREADY COMMUNICATING BETWEEN THE STENT AND THE LEFT POSTERIOR ANEURYSMAL SAC. THE PATIENT IS BEING MONITORED AND WAS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338057 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA25-60-/I13-40 W11-6189-006

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR