BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 3062036 · Received April 16, 2013

    Report

    Report Number
    2015691-2013-19830
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 AN BIOPROSTHETIC VALVES IS DEPENDENT ON BOTH PATIENT FACTORS AND 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. NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    IT WAS LEARNED THAT THE TRANSCATHETER PROCEDURE WAS COMPLETED AND PT REMAINED STABLE THROUGHOUT THE PROCEDURE AND WAS TRANSFERRED IN THAT SAME CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINICAL AFFAIRS THAT A PATIENT WAS DIAGNOSED WITH AORTIC STENOSIS OF AN EDWARDS BIOPROSTHETIC AORTIC VALVE AFTER AN IMPLANT DURATION OF APPROXIMATELY 11 YEARS. THE PATIENT IS SCHEDULED TO HAVE A TRANCATHETER BIOPROSTHETIC VALVE IMPLANTED INSIDE OF THE EXISTING EDWARDS VALVE ON (B)(6) 2013. ADDITIONAL INFORMATION AND PATIENT STATUS POST PROCEDURE WILL BE REPORTED ONCE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162620 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R