BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3061931 · Received April 16, 2013

    Report

    Report Number
    2015691-2013-19827
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 20, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. 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 CALCIFICATION LIKELY CAUSED THE PATIENT'S STENOSIS. 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 AVAILALBE 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 AND 3 MONTHS DUE TO STENOSIS AND CALCIFICATION. PER THE OP REPORT, THE PATIENT HAD BEEN EXPERIENCING PROGRESSIVE SHORTNESS OF BREATH AND ON CARDIAC CATHETERIZATION WAS FOUND TO HAVE A PATENT LEFT MAMMARY TO HIS LAD AND A VEIN GRAFT TO THE MARGINAL. HIS PROSTHETIC AORTIC VALVE WAS NOTED TO BE SEVERELY STENOTIC ON ECHO. ALSO NOTED TO HAVE SEVERE MITRAL REGURGITATION. UPON EXPLANTATION OF THE VALVE, IT WAS CALCIFIED AND HIGHLY STENOTIC. THE EXPLANTED DEVICE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE. ON TEE, THE AORTIC VALVE WAS FUNCTIONING NORMALLY WITH NO SIGNIFICANT GRADIENT. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162895 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R