BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2840352 · Received November 20, 2012

    Report

    Report Number
    2015691-2012-18675
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 23, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE EXPLANTED VALVE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED, IT APPEARS THAT THE STENOSIS WAS LIKELY CAUSED BY THE CALCIFICATION AND FIBROTIC GROWTH. 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 OTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 7 YEARS. THROUGH FOLLOW-UP WITH THE HEALTHCARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO PROSTHETIC AORTIC VALVE STENOSIS. IT WAS ALSO NOTED THAT THE DEVICE WAS CALCIFIED AND FIBROTIC. PER THE HEALTHCARE PROVIDER, THERE WAS NO MALFUNCTION OF THE EXPLANTED VALVE. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R