BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 6668906 · Received June 26, 2017

    Report

    Report Number
    2015691-2017-01844
    Event Type
    Injury
    Date Received
    June 26, 2017
    Date of Event
    January 1, 2008
    Report Date
    June 2, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINICAL OBSERVATION IN THIS CANNOT BE CONFIRMED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR EVALUATION. CALCIFICATION OF VALVES OCCURS AS A PROGRESSIVE, TIME-DEPENDENT PROCESS. TISSUE VALVE CALCIFICATION IS INITIATED PRIMARILY WITHIN RESIDUAL CELLS THAT HAVE BEEN DEVITALIZED. INITIAL CALCIFICATION DEPOSITS EVENTUALLY ENLARGE AND GROW INTO A MASS, WHICH STIFFEN AND WEAKEN THE TISSUE AND THEREBY CAUSE THE PROSTHESIS TO MALFUNCTION. THE MINERALIZATION OF A BIOMATERIAL IS GENERALLY ENHANCED AT THE SITES OF INTENSE MECHANICAL DEFORMATIONS GENERATED BY MOTION, SUCH AS THE POINTS OF FLEXION IN HEART VALVES. ULTIMATELY, THE RESULT OF CALCIFICATION IS VALVE FAILURE DUE TO TEARING OR STENOSIS. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.), MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE, AND GLUTARALDEHYDE FIXATION OF TISSUE. OF THESE, THE FIXATION PROCESS IS A RELATIVELY MINOR CONTRIBUTOR TO CALCIFICATION FOR EDWARDS' TISSUE VALVES DUE TO ANTI-CALCIFICATION TREATMENTS DURING MANUFACTURING. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESES FROM CALCIFYING. THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE INFORMATION. HOWEVER, THE CALCIFICATION IN THIS CASE WAS MOST LIKELY IMPACTED BY THE PROGRESSION OF THE PATIENT¿S UNDERLYING VALVULAR DISEASE PATHOLOGY. 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

    THE FOLLOWING ARTICLE WAS REVIEWED: PERCUTANEOUS EDWARDS SAPIEN VALVE IMPLANTATION IN THE TRICUSPID POSITION: CASE REPORT AND REVIEW OF LITERATURE BY ELKE S. HOENDERMIS, MD, PHD; YVONNE L. DOUGLAS, MD, PHD; AD F. M. VAN DEN HEUVEL, MD, PHD. IT WAS LEARNED THAT A 33 MM CARPENTIER-EDWARDS VALVE, IMPLANTED IN THE TRICUSPID POSITION IN A (B)(6) YEAR-OLD FEMALE PATIENT WITH EBSTEIN´S ANOMALY AND VENTRICULAR DYSFUNCTION, WAS EXPLANTED AFTER APPROXIMATELY SIX (6) YEARS DUE TO SEVERE CALCIFICATION AND STENOSIS. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER PROSTHETIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448048 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R