BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 3843977 · Received June 2, 2014

    Report

    Report Number
    2015691-2014-01276
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 6, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. BIOPROSTHETIC VALVE DYSFUNCTION ENCOMPASSES MULTIPLE FAILURE MODES/MECHANISMS,THAT MAY OCCUR SINGULARLY OR CONCOMITANTLY. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF THESE FAILURES 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 (REMAINS IMPLANTED), THE SPECIFIC MECHANISM LEADING TO THIS EVENT CANNOT BE IDENTIFIED OR EVALUATED. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT. EDWARDS WILL CONTINUE TO MONITOR ALL EVENTS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT DISTRIBUTED, MARKETED, OR SOLD IN THE U.S.; HOWEVER, IT IS SIMILAR TO MODEL NO. 2800 WHICH IS MARKETED IN THE U.S. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO PRODUCT BEING RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS LEARNED THAT AN EDWARDS AORTIC BIOPROSTHETIC VALVE HAD DETERIORATED CAUSING AORTIC CENTRAL REGURGITATION AFTER AN IMPLANT DURATION OF APPROXIMATELY ELEVEN (11) YEARS. THE PATIENT UNDERWENT PROCEDURE TO IMPLANT AN EDWARDS TRANSCATHETER AORTIC VALVE WITHIN THE SUBJECT DEVICE (VALVE IN VALVE). THE PATIENT WAS REPORTED AS STABLE POST THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321207 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R