BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 4171687 · Received October 15, 2014

    Report

    Report Number
    2031527-2014-00295
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    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

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. ONLY MEDICAL RECORDS WITHOUT IMAGING WERE PROVIDED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE. THE REVIEW CONCLUDED THAT PRODUCT USE WAS INCONGRUENT WITH THE IFU DUE TO: THE RIGHT ILIAC ARTERY DIAMETER OF 5.6 CM AND THE ABSENCE OF AN ABDOMINAL ANEURYSM. CAUTIONARY PRODUCT USE CONDITION OF END STAGE RENAL DISEASE AND THE INABILITY TO TOLERATE CONTRASTED CT SURVEILLANCE MIGHT HAVE ALSO CONTRIBUTED TO THE EVENT. THE PATIENT'S USE OF ANTIPLATELET THERAPY MIGHT HAVE BEEN A CONTRIBUTING FACTOR DUE TO THE INCREASED RISK FOR BLEEDING COMPLICATIONS. THERE ALSO WAS A PERSISTENT TYPE II ENDOLEAK WITH A LUMBAR SOURCE; ITS LOCATION WAS UNCLEAR, WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. 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 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. BASED UPON THE INVESTIGATION FINDINGS, A LIKELY ROOT CAUSE HAS BEEN DETERMINED TO BE THE USE OF THE DEVICE IN A NON-ANEURYSMAL ABDOMINAL AORTA (OFF-LABEL) AND LESS OPTIMAL PATIENT ANATOMY/CONDITION; HOWEVER, THE EXACT ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED BASED UPON AVAILABLE INFORMATION.

    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 PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 6 MONTHS POST IMPLANT OF A BIFURCATED DEVICE AND A LIMB EXTENSION AN ENDOLEAK BETWEEN THE DEVICES WAS IDENTIFIED. THE PHYSICIAN BROUGHT THE PATIENT BACK AND IMPLANTED A SECOND LIMB EXTENSION; HOWEVER, A SMALL ENDOLEAK REMAINED. AN ADDITIONAL LIMB EXTENSION WAS IMPLANTED, WITHOUT ANY CHANGE. THE PHYSICIAN AT THAT POINT WAS UNSURE WHERE THE ENDOLEAK WAS COMING FROM. THE PROCEDURE WAS CONCLUDED AND THE PHYSICIAN WILL MONITOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653380 AFX SYSTEM LIMB EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. I20-13/C88F SA 1047374-029

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention