BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 5335957 · Received December 30, 2015

    Report

    Report Number
    2015691-2015-03586
    Event Type
    Injury
    Date Received
    December 30, 2015
    Date of Event
    March 31, 2014
    Report Date
    December 7, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION WERE UNSUCCESSFUL. STRUCTURAL VALVE DETERIORATION (SVD) CAN RESULT IN REGURGITATION AND/OR STENOSIS. IN THIS CASE, IT WAS REPORTED THAT SVD LED TO REGURGITATION AND STENOSIS. MITRAL REGURGITATION (MR) IN BIOPROSTHETIC HEART VALVES OCCURS WHEN THE VALVE DOES NOT CLOSE PROPERLY IN SYSTOLIC PHASE, WHICH RESULTS IN RETROGRADE FLOW OF BLOOD INTO THE LEFT ATRIUM. THE TYPE AND CAUSE OF REGURGITATION VARIES DEPENDING UPON MULTIPLE FACTORS. REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION. HOWEVER, ADVANCES IN VALVE DESIGN AND BIOPROSTHETIC MATERIAL HAVE BEEN MADE WITH THE INTENTION OF REDUCING LEAKS BY PROVIDING MORE EFFICIENT HEMODYNAMICS AND LONGER TISSUE DURABILITY. BASED ON THE INFORMATION RECEIVED THE ROOT CAUSE OF THE EVENT REMAINS INDETERMINABLE. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. 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

    EDWARDS RECEIVED THROUGH MEDICAL ARTICLE "FIRST IN HUMAN IMPLANTATION OF THE MECHANICAL EXPANDING LOTUSVR VALVE IN DEGENERATED SURGICAL VALVES IN MITRAL POSITION" AUTHOR: ULRICH SCHAEFER, ET AL. PUBLISHED ON: CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 86:1280-1286 (2015). INTRODUCTION: IMPLANTATION OF TRANSCATHETER HEART VALVES (THV) INTO DEGENERATED SURGICAL VALVES IS AN EMERGING THERAPY FOR SELECTED HIGH-RISK PATIENTS. ALTHOUGH, CE MARK OF MOST THV IS LIMITED FOR NATIVE AORTIC VALVULAR STENOSIS, TRANSCATHETER VALVE IMPLANTATION INTO DEGENERATED BIOPROSTHESES, EVEN IN MITRAL POSITION IS VERY INTRIGUING. METHODS AND RESULTS: AFTER PLACEMENT OF A CEREBRAL PROTECTION DEVICE (CLARET SENTINELVR ), THREE CONSECUTIVE PATIENTS (AGE, 79.066.1; LOG EUROSCORE I: 33.369.2%) WITH A DEGENERATED MITRAL BIOPROSTHESIS WERE TREATED BY TRANSAPICAL IMPLANTATION OF THE LOTUSVR VALVE (BOSTON SCIENTIFIC INC.). IN ADDITION, A SWANGANZ CATHETER WAS INTRODUCED IN THE PULMONARY ARTERY FOR HEMODYNAMIC ASSESSMENTS ALL PATIENTS. PROCEDURAL SUCCESS WAS 100%. VALVE IMPLANTATION WAS PERFORMED WITHOUT RAPID VENTRICULAR PACING. RESHEATING WAS PERFORMED IN TWO PATIENTS DUE TO SUBOPTIMAL INITIAL POSITIONING. INVASIVE ONLINE HEMODYNAMICS REVEALED STABLE BLOOD PRESSURE IN ALL PATIENTS. AFTER LOTUSVR VALVE IMPLANTATION, VALVULAR MITRAL REGURGITATION WAS COMPLETELY ELIMINATED IN ALL PATIENTS. ONE PATIENT HAD A MILD PARAVALVULAR LEAK OF THE SURGICAL BIOPROSTHESIS, WHICH WAS PRESENT BEFORE IMPLANTATION. INVASIVE RIGHT AND LEFT HEART HEMODYNAMICS SHOWED AN IMMEDIATE IMPROVEMENT AFTER LOTUSVR VALVE IMPLANTATION. MEAN MITRAL SURFACE AREA (2.160.2 CM2) AND MEAN GRADIENT (3.762.1 MM HG) DEMONSTRATED SATISFACTORY RESULTS. ALL PATIENTS WERE IMMEDIATELY EXTUBATED AND DISCHARGED FROM THE HOSPITAL WITHOUT ANY ADVERSE EVENT. CONCLUSIONS: THIS STUDY DEMONSTRATES FOR THE FIRST TIME THE FEASIBILITY OF TRANSAPICAL LOTUSVR VALVE IMPLANTATION IN DEGENERATED MITRAL BIOPROSTHESES. THE CONTROLLED MECHANICAL LOTUSVR VALVE EXPANSION WITH REMARKABLY STABLE HEMODYNAMICS THROUGHOUT THE PROCEDURE OFFERS A NEW AND VALUABLE TREATMENT OPTION. IN THE CONTEXT OF THIS ARTICLE A VALVE IN VALVE IN A 29MM EDWARDS VALVE WAS IDENTIFIED AFTER AN IMPLANT DURATION OF 8 YEARS DUE TO DEGENERATION LEADING TO STENOSIS AND REGURGITATION GRADE I (ECHO MEAN GRADIENT 10 MMHG, EOA 1CM2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859454 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R