BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 1961930 · Received January 14, 2011

    Report

    Report Number
    2015691-2011-14683
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 15, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: THE EXPLANTED VALVE WAS RETURNED TO EDWARDS FOR ANALYSIS. EVALUATION: RESEARCH AND DEVELOPMENT COMPLETED THE FUNCTIONAL TEST AND CONCLUDED WITH THE FOLLOWING: "THIS VALVE WAS REPORTEDLY EXPLANTED AT IMPLANT DUE TO A "SERIOUS CENTRAL REGURGITATION (2+)", WHICH COULD NOT BE REPRODUCED BY EDWARDS¿ STANDARDIZED IN VITRO TESTS. SINCE NO ECHOCARDIOGRAPHY WAS PROVIDED, THE BEHAVIOR OF THE VALVE AND THE REGURGITATION OBSERVED IN VIVO CANNOT BE CONFIRMED. EDWARDS STANDARDIZED IN VITRO TESTING OF THE AS-RECEIVED VALVE SHOWED A LOW 3.0% TOTAL REGURGITANT FRACTION, WHICH IS ABOUT 6 TIMES LESS THAN THE 20% MAXIMUM ALLOWED PER ISO5840:2005 FOR THIS VALVE SIZE. THIS AMOUNT OF LEAKAGE WOULD NOT BE CONSIDERED 2+ LEVEL REGURGITATION, PER THE ACC/AHA 2006 GUIDELINES FOR THE MANAGEMENT OF PATIENTS WITH VALVULAR HEART DISEASE. IT IS POSSIBLE, HOWEVER, THAT THE RESULTS FROM IN VITRO TESTING MAY BE DIFFERENT FROM THOSE OBSERVED IN VIVO DUE TO THE POST-EXPLANT EXPOSURE OF THE VALVE TO THE FIXATIVE STORAGE SOLUTION AND THE DIFFERENT CONDITIONS UNDER WHICH THE VALVE FUNCTIONED. PRE-PUMP AND POST-PUMP ECHO IMAGES WERE SUBMITTED AND REVIEWED BY AN EXTERNAL PHYSICIAN CONSULTANT. IMPRESSION: "THERE IS MILD CENTRAL MITRAL REGURGITATION THAT IS NORMAL IN ASSOCIATION WITH THE EDWARDS PERICARDIAL BIOPROSTHESIS. COLOR-FLOW DOPPLER INTERROGATION OF THE VALVE USED AN INAPPROPRIATELY LOW NYQUIST LIMIT THAT IS RESPONSIBLE FOR OVER-STATING THE SIZE OF THE COLOR-FLOW JET. THERE IS NO EVIDENCE OF PROSTHESIS DYSFUNCTION." FURTHERMORE, EVALUATION OF THE RETURNED VALVE AND ECHO REVEALS NO EVIDENCE OF A PRODUCT MALFUNCTION OR MANUFACTURER DEFECT.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: IT IS INDICATED THAT THE REGURGITATION WAS DETECTED ON ECHO. ECHO HAS BEEN REQUESTED BUT NOT RECEIVED. DEVICE IS TO BE RETURNED FOR EVALUATION. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. INVESTIGATION IS ON-GOING.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE WAS EXPLANTED AT IMPLANT DUE TO REGURGITATION DETECTED ON ECHO. PER THE CUSTOMER REPORT, MITRAL VALVE IMPLANTED WITHOUT COMPLICATION OR DIFFICULTY BUT WHEN PATIENT WAS TAKEN OFF BYPASS, THERE WAS A SERIOUS CENTRAL REGURGITATION (2+) WHICH DID NOT RESOLVE. PATIENT PRESSURES WERE GOOD. VALVE NEEDED TO BE REMOVED AND PORCINE VALVE IMPLANTED. UPON REMOVAL OF VALVE, NO SUTURE LOOPS WERE EVIDENT AND SURGEON IS CONFIDENT THAT THERE WAS NO USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX 08C060

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R