BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 4110670 · Received September 23, 2014

    Report

    Report Number
    2031527-2014-00286
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    BASED UPON THE CLINICAL REVIEW, THE REPORTED STENT MIGRATION AND ENDOLEAK WAS CONFIRMED. BASED UPON THE INVESTIGATION FINDINGS, A ROOT CAUSE FOR THE REPORTED DIFFICULTY IS COMPLEX, BUT APPEARS TO BE THE RESULT OF PATIENT DISEASE PROGRESSION, A MAJOR FACTOR BEING THE UNRESOLVED, CONFIRMED TYPE II ENDOLEAK. OFF-LABEL USE OF THE DEVICES ARE ADDITIONAL FACTORS THAT LIKELY CONTRIBUTED TO THE ULTIMATE PATIENT OUTCOME. 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 THAT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 21 MONTHS POST IMPLANT OF A BIFURCATED DEVICE, AND A SUPRARENAL AORTIC EXTENSION, A COMPUTED TOMOGRAPHY REVEALED A SEPARATION BETWEEN THE TWO COMPONENTS. REPORTEDLY, THERE WAS A DEVICE SEPARATION BETWEEN THE PROXIMAL EXTENSION AND THE MAIN BODY, AND DISTAL LEFT HYPO NEEDED TO BE COVERED. THE PHYSICIAN TREATED THE PATIENT WITH TWO ADDITIONAL AORTIC EXTENSIONS, AND A LIMB EXTENSION. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589856 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT ( MIH ENDOLOGIX, INC. A34-34/C100-O20 1032435-009

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention