BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESES

    MDR report key: 2954749 · Received February 11, 2013

    Report

    Report Number
    2015691-2013-19246
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL TESTING WAS COMPLETED BY RESEARCH AND DEVELOPMENT. THE SUMMARY AND CONCLUSION STATES: THIS VALVE WAS IMPLANTED IN THE TRICUSPID POSITION AND EXPLANTED AT IMPLANT DUE TO 'A LARGER THAN USUAL CENTRAL LEAK WHICH WAS CLEARLY EVIDENT ON TEE FOLLOWING WEANING FROM BYPASS.' NO ECHOCARDIOGRAPHY RECORDING WAS PROVIDED, THUS THE REPORTED BEHAVIOR AND FUNCTIONALITY OF THE VALVE IN VIVO CANNOT BE CONFIRMED. MODEL 7300TFX BIOPROSTHESIS IS DESIGNED FOR MITRAL POSITION, WHICH HAS DIFFERENT HEMODYNAMICS COMPARED TO THE TRICUSPID POSITION WHERE THE SYSTOLIC PRESSURE IS SIGNIFICANTLY LOWER. THEREFORE, A SMALL AMOUNT OF LEAKAGE THROUGH THIS TYPE OF BIOPROSTHETIC VALVE CAN BE EXPECTED IF IT IS IMPLANTED IN THE TRICUSPID POSITION. HOWEVER, IT IS UNCLEAR WHETHER OR NOT THE LEAFLET CREASE PRESENTED IN THIS PARTICULAR VALVE CONTRIBUTED TO THE 'LARGER THAN USUAL CENTRAL LEAK' OBSERVED IN VIVO. EDWARDS' STANDARDIZED IN VITRO TESTING UNDER NORMAL PHYSIOLOGICAL CONDITIONS DEMONSTRATED THAT THE TOTAL REGURGITANT FRACTION (TRF) OF THE VALVE IS 4.4%, WHICH IS FOUR TIMES LESS THAN THE 20% MAXIMUM ALLOWED FOR THIS SIZE OF MITRAL VALVE IN THE MINIMUM PERFORMANCE REQUIREMENTS LISTED IN ISO5840:2005.

    Additional Manufacturer Narrative · 1

    THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN BUT HAS NOT BEEN RECEIVED. NO PATIENT HISTORY OR CONDITION PROVIDED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: REPORT OF DEVICE EXPLANTED AT IMPLANT DUE TO REGURGITATION, CANNOT BE CONFIRMED BASED ON VISUAL OBSERVATION. NO VISIBLE INCONSISTENCIES OBSERVED ON LEAFLETS. SEWING RING EXPOSED BETWEEN COMMISSURE 2 AND 3. THE WIREFORM WAS INTACT, AS EVIDENT IN THE X-RAY. METHOD: = X-RAY. THE DEVICE WAS EVALUATED BY OUR PRODUCT EVALUATION LABORATORY. ADDITIONAL FUNCTIONAL TESTING HAS BEEN REQUESTED AS THERE WERE NO INCONSISTENCIES OBSERVED. THE VALVE WILL BE SENT TO RESEARCH AND DEVELOPMENT FOR FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    REPORTEDLY, A 31MM MITRAL VALVE WAS EXPLANTED DUE TO CENTRAL MODERATE REGURGITATION." NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59498 CARPENTIER-EDWARDS® PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESES HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 7300TFX 12D037

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R