BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 7614528 · Received June 19, 2018

    Report

    Report Number
    2015691-2018-02340
    Event Type
    Injury
    Date Received
    June 19, 2018
    Date of Event
    November 1, 2016
    Report Date
    May 30, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AORTIC REGURGITATION (AR) IN BIOPROSTHETIC HEART VALVES, ALSO KNOWN AS AORTIC INSUFFICIENCY, OCCURS WHEN THE VALVE DOES NOT CLOSE PROPERLY IN DIASTOLIC PHASE, WHICH RESULTS IN RETROGRADE FLOW OF BLOOD INTO THE LEFT VENTRICLE. TRIVIAL/TRACE TO MILD AMOUNTS OF AR ARE NOT UNUSUAL POST OPERATIVELY IN BIOPROSTHETIC VALVES. THIS IS USUALLY TOLERATED BY THE PATIENTS. IF THE REGURGITATION WORSENS OR BECOMES SYMPTOMATIC, REOPERATION MAY BE NECESSARY. REGURGITATION IS CONSIDERED TO BE A PERIVALVULAR LEAK (PVL) IF A TURBULENT ECCENTRIC JET ORIGINATES BETWEEN THE BIOPROSTHETIC SEWING RING AND THE ANNULUS. WHILE THE MAJORITY OF AFFECTED PATIENTS ARE ASYMPTOMATIC, PVL, WHEN SEVERE, CAN LEAD TO SIGNIFICANT MORBIDITY INCLUDING HEART FAILURE AND HEMOLYTIC ANEMIA. STRUCTURAL VALVE DETERIORATION (SVD) CAN, AND TYPICALLY DOES, LEAD TO CHRONIC CENTRAL LEAKS OVER A PERIOD OF TIME. 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. CENTRAL REGURGITATION CAN ALSO DEVELOP PROGRESSIVELY IF HOST FIBROTIC TISSUE GROWS ONTO THE BIOPROSTHETIC VALVE. THE GROWTH MAY INTERFERE WITH FUNCTIONALITY OF THE DEVICE AS THE LEAFLET MOTION MAY BE RESTRICTED LEADING TO ABNORMAL COAPTATION. THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE INFORMATION. HOWEVER, THE EVENT IN THIS CASE WAS MOST LIKELY IMPACTED BY THE PROGRESSION OF THE PATIENT¿S UNDERLYING VALVULAR DISEASE PATHOLOGY WITH OR WITHOUT STRUCTURAL VALVE DETERIORATION AND/OR NONSTRUCTURAL DYSFUNCTION. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT. 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 EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    DURING REVIEW OF A LIVE CASE PRESENTED AT THE (B)(6), EDWARDS LEARNT THAT THIS PATIENT WITH A 23MM EDWARDS SURGICAL VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A RE-INTERVENTION TO TREAT A MAJOR PARAVALVULAR LEAK (PVL) AFTER AN IMPLANT DURATION OF APPROXIMATELY 13 YEARS. AS REPORTED, THE PATIENT WAS ADMITTED FOR ACUTE PULMONARY EDEMA IN (B)(6) 2016. ON TTE-TEE A MAJOR PVL AND MILD CENTRAL AORTIC REGURGITATION WERE DETECTED. A PERCUTANEOUS CLOSURE VIA TRANSFEMORAL/TRANSRADIAL ACCESS WAS PERFORMED TO TREAT THE PVL. POST PROCEDURE, THE PATIENT WAS DISCHARGED HOME WITH OPTIMIZATION OF MEDICAL THERAPY. HOWEVER, IN (B)(6) 2017, THE PATIENT WAS READMITTED TO THE HOSPITAL FOR ACUTE PULMONARY EDEMA AND DYSPNEA (NYHA CLASS III). A NEW ATTEMPT VIA TRANS-APICAL ACCESS WAS PERFORMED IN (B)(6) 2017, BUT IT FAILED. AS REPORTED, AFTER 3 ATTEMPTS AND 2 BALLOON RUPTURES THE VALVE WAS NOT FRACTURED AND THE CENTRAL AORTIC REGURGITATION HAD WORSENED. THEREFORE, A 26MM EDWARDS TRANSCATHETER HEART VALVE WAS IMPLANTED WITHIN THE 23MM EDWARDS SURGICAL VALVE AND THE PVL WAS RESOLVED. THE PATIENT WAS DISCHARGED ON POD #7. ONE (1) MONTH LATER, THE PATIENT'S DYSPNEA WAS NYHA CLASS I.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459369 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R