BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2991757 · Received March 6, 2013

    Report

    Report Number
    2015691-2013-19453
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 21, 2013
    Report Date
    February 6, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 COULD NOT BE CONFIRMED, IT APPEARS THAT THE STENOSIS AND INSUFFICIENCY WERE LIKELY CAUSED BY THE CALCIFIED VALVE LEAFLETS. 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 PROSTHETIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 8 YEARS AND 7 MONTHS DUE TO AORTIC STENOSIS (AS) AND AORTIC INSUFFICIENCY (AI). PER THE OP REPORT, THE PROSTHETIC VALVE LEAFLETS WERE CALCIFIED, RIGID, AND WERE BASICALLY STUCK IN WITH A CENTRAL OPENING, RESULTING IN AS AND AI. THE DEVICE WAS REMOVED AND A NEW EDWARDS BIOPROSTHETIC VALVE WAS SEATED NICELY. TEE SHOWED A NORMALLY FUNCTIONING AORTIC VALVE. THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE WELL. THE HEALTHCARE PROVIDER ALSO NOTED THAT THERE WAS NO MALFUNCTION OF THE EXPLANTED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96255 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000 JV9111

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R