BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 3011788 · Received March 19, 2013

    Report

    Report Number
    2015691-2013-19593
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 19, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    COPIES OF THE PATIENT'S MEDICAL RECORDS WERE RECEIVED WHICH INDICATE THAT THIS VALVE WAS EXPLANTED DUE TO MITRAL STENOSIS AND MITRAL REGURGITATION. PER THE OP REPORT, THE MITRAL PROSTHESIS WAS HEAVILY CALCIFIED AND SCLEROTIC AND REGURGITANT. A NEW EDWARDS BIOPROSTHETIC VALVE WAS IMPLANTED. AFTER THE PATIENT WAS WARMED, THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS WITH EXCELLENT HEMODYNAMICS. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE SOURCE OF THE REPORTED CALCIFICATION COULD NOT BE ASSESSED. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED, IT APPEARS THAT THE STENOSIS AND REGURGITATION WAS LIKELY CAUSED BY THE CALCIFICATION. CALCIFICATION IS A WELL RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 9 YEARS AND 5 MONTHS. THE REASON FOR EXPLANT IS UNKNOWN. DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE. THE DEVICE WAS REPLACED WITH ANOTHER EDWARDS VALVE. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114522 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R