BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 6814215 · Received August 23, 2017

    Report

    Report Number
    2015691-2017-02601
    Event Type
    Injury
    Date Received
    August 23, 2017
    Date of Event
    November 1, 2008
    Report Date
    July 28, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO MODEL #6625-LP; CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS; PMA #P870077. BIOPROSTHETIC TISSUE VALVES CAN DETERIORATE WITH TIME AND EVENTUALLY FAIL CONTRIBUTING TO REGURGITATION AND/OR STENOSIS. STRUCTURAL VALVE DETERIORATION (SVD) IS THE MOST COMMON REASON FOR BIOPROSTHESES EXPLANTS/REPLACEMENTS 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. THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE INFORMATION. HOWEVER, THIS EVENT WAS MOST LIKELY IMPACTED BY THE PROGRESSION OF THE PATIENT¿S UNDERLYING VALVULAR DISEASE PATHOLOGY WITH STRUCTURAL VALVE DETERIORATION. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED, AS THE DEVICE SERIAL NUMBER WAS NOT PROVIDED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS REVIEWED THE ARTICLE, "TREATMENT OF AORTIC, MITRAL AND TRICUSPID STRUCTURAL BIOPROSTHETIC VALVE DETERIORATION USING THE VALVE-IN-VALVE TECHNIQUE" BY PABLO CODNER ET AL. IT WAS REPORTED THAT A TOTAL OF 33 CONSECUTIVE PATIENTS WITH SYMPTOMATIC STRUCTURAL BIOPROSTHETIC VALVE DETERIORATION WERE TREATED USING THE VALVE-IN-VALVE (VIV) TECHNIQUE. IN THE AUTHORS¿ EXPERIENCE, THE VIV TECHNIQUE FOR THE TREATMENT OF A WIDE RANGE OF BIOPROSTHETIC VALVE DETERIORATION MODES OF FAILURE IN DIFFERENT VALVE POSITIONS IS SAFE AND VERY EFFECTIVE. OF THE 33 PATIENTS, IT WAS REPORTED THAT THIS (B)(6)-YEAR-OLD MALE PATIENT (#7 MITRAL PATIENT) WITH A CE SAV 27 MM VALVE, IMPLANTED APPROXIMATELY 11 YEARS, UNDERWENT A VIV PROCEDURE DUE TO STRUCTURAL BIOPROSTHETIC VALVE DETERIORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593463 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 665027MM

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R