BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 5062185 · Received September 8, 2015

    Report

    Report Number
    2015691-2015-02338
    Event Type
    Injury
    Date Received
    September 8, 2015
    Date of Event
    June 17, 2014
    Report Date
    August 11, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE - THE DEVICE WAS NOT RETURNED TO MANUFACTURER AS IT REMAINS IMPLANTED. STRUCTURAL VALVE DETERIORATION (SVD) IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANT AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF SVD INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. HOWEVER, WITHOUT RETURN OF DEVICE AND EVALUATION, THE SPECIFIC MECHANISM LEADING TO THIS EXPLANT CANNOT BE IDENTIFIED OR EVALUATED. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    AS REPORTED THROUGH WRITTEN ARTICLE "TREATMENT OF A SEVERELY DEGENERATED MITRAL BIOPROSTHESIS WITH TRANSCATHETER VALVE-IN-VALVE IMPLANTATION" AUTHOR: MICHAEL CHRISSOHERIS, ET AL. PUBLISHED HELLENIC J CARDIOL 2015; 56:347-350. EDWARDS LEARNED OF A 27MM MITRAL BIOPROTHESIS THE REQUIRED VALVE IN VALVE INTERVENTION AFTER AN IMPLANT DURATION OF 10 YEARS DUE TO DEGENERATION LEADING TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH PROGRESSIVE WORSENING OF HEART FAILURE SYMPTOMS OVER THE PREVIOUS 18 MONTHS. THE PATIENT WAS IMPLANTED WITH A 29MM TRANSCATHETER VALVE SUCCESSFULLY VIA TRANSAPICAL APPROACH. THE PATIENT IS NOTED AS DISCHARGED WITH EXCELLENT IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592798 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R