BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART-VALVE, REPLACEMENT

    MDR report key: 7985126 · Received October 19, 2018

    Report

    Report Number
    2015691-2018-04290
    Event Type
    Injury
    Date Received
    October 19, 2018
    Date of Event
    April 28, 2018
    Report Date
    September 27, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS THE DEVICE SERIAL NUMBER WAS NOT PROVIDED. BIOPROSTHETIC TISSUE VALVES CAN DETERIORATE WITH TIME AND EVENTUALLY FAIL CONTRIBUTING TO REGURGITATION AND/OR STENOSIS. THERE CAN BE A NUMBER OF POTENTIAL KNOWN AND UNKNOWN PATIENT RELATED CONTRIBUTING FACTORS. STRUCTURAL VALVE DETERIORATION (SVD), A COMMON REASON FOR BIOPROSTHESIS EXPLANT OR REOPERATION, ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFIC AND NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES, OCCURRING SINGULARLY OR CONCOMITANTLY, MAY CONTRIBUTE TO STENOSIS AND/OR REGURGITATION. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR STENOSIS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THROUGH REVIEW OF CASE PRESENTED DURING THE TCTAP 2018 IN KOREA "A CASE OF SUCCESSFUL VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT WITH BIOPROSTHETIC VALVE FRACTURE" BY SPEAKER SANG YONG OM, THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: A (B)(6) PATIENT WITH A 21MM VALVE IMPLANTED IN THE AORTIC POSITION UNDERWENT A VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 17 YEARS DUE TO DEGENERATION (AVA = 0.61 CM2, PEAK / MEAN PG = 81 / 48 MM HG, V MAX = 4.5 M/S, EF= 66 %). A NON-EDWARDS VALVE WAS IMPLANTED WITHIN THE DISABLED EDWARDS VALVE. AS REPORTED THE PATIENT PRESENTED WITH DYSPNEA (NYHA FC II).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824120 HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention