BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 3081606 · Received April 29, 2013

    Report

    Report Number
    2015691-2013-19934
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTATION OF A TRANSCATHETER HEART VALVE INSIDE A DEGENERATED ONE IS A LESS INVASIVE PROCEDURE TO TREAT VALVULAR DISEASE. STENOSIS OF A BIOPROSTHETIC VALVE IS DEPENDENT ON BOTH PATIENT FACTORS AN INTRINSIC PROPERTIES OF BIOPROSTHETIC VALVES. WITHOUT RETURN OF DEVICE, THE NATURE OF THE REPORTED SEVERE STENOSIS CANNOT BE IDENTIFIED OR EVALUATED. STENOSIS MAY BE DUE TO CALCIFIC TISSUE DEGENERATION, NON-CALCIFIC TISSUE DEGENERATION, AND/OR NON-STRUCTURAL DYSFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SALES DEPARTMENT BY SURGEON THAT A 27MM EDWARDS CARPENTIER IMPLANTED IN 2006 WAS NOTED ON TEE TO HAVE 2 OF THE 3 LEAFLETS COMPLETELY FUSED AND ONLY ONE LEAFLET MOVING. THE PATIENT UNDERWENT A TRANSAPICAL TRANSCATHETER MITRAL VALVE REPLACEMENT INSIDE THE STENOTIC BIOPROSTHETIC MITRAL VALVE IN A VALVE IN VALVE FASHION. THE OPERATIVE REPORT INDICATES "TEE WAS PERFORMED BY THE ANESTHESIA TEAM, AND THIS SHOWED THAT THE AORTIC VALVE WAS CRITICALLY STENOTIC. IT ALSO SHOWED THAT THE MITRAL VALVE PROSTHESIS WAS HIGHLY DYSFUNCTIONAL, AS 2 OF THE LEAFLETS WERE IMMOBILE AND ONLY 1 LEAFLET OPENED. THE GRADIENTS ACROSS THE MITRAL VALVE WERE OVER 10 MMHG PEAK AND ABOUT 10 MMHG MEAN, SHOWING SEVERE MITRAL STENOSIS....[AFTER VALVE IMPLANTATION] THE PATIENT TOLERATED THIS VERY COMPLEX PROCEDURE...AND RETURNED TO THE INTENSIVE CARE UNITE IN STABLE CONDITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184134 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 5L2076

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R