BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 ULTRA HEART VALVE

    MDR report key: 11971495 · Received June 9, 2021

    Report

    Report Number
    2015691-2021-03402
    Event Type
    Death
    Date Received
    June 9, 2021
    Date of Event
    January 1, 2021
    Report Date
    June 10, 2021
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    NPU
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT PROVIDES DATA FROM THV/TVT REGISTRY EXEMPTION NUMBER E2016006 AND SUMMARIZES 1 EVENT OF MITRAL VALVE REINTERVENTION FOR THE SAPIEN 3 ULTRA VALVE IN THE MITRAL POSITION. THE 'TIME TO EVENT' (TTE, IN DAYS) FOR THIS EVENT WAS 0. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE IS: (B)(4). MITRAL VALVE RE-INTERVENTION IN THE FOLLOW-UP PERIOD (IN THE ABSENCE OF PROSTHETIC CARDIAC VALVE THROMBOSIS) WILL TYPICALLY RESULT FROM ON-GOING OR WORSENING REGURGITATION, VALVE DEGENERATION RELATED TO THE FORMATION OF CALCIFICATION OR PANNUS, OR VALVE MIGRATION. THESE EVENTS ARE IDENTIFIED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU) AS POTENTIAL RISKS ASSOCIATED WITH THE USE OF THE THV. REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO SEVERAL ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, LEAFLET THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. REGURGITATION MAY ALSO DEVELOP PROGRESSIVELY IF HOST FIBROTIC TISSUE, OR PANNUS, GROWS ONTO THE BIOPROSTHETIC VALVE. PANNUS, A CAUSE OF NONSTRUCTURAL DYSFUNCTION, MAY INTERFERE WITH FUNCTIONALITY OF THE DEVICE BY RESTRICTING THE LEAFLET MOTION LEADING TO ABNORMAL COAPTATION. CALCIFICATION IS A WELL-RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISM OF CALCIFICATION OF BIOMATERIALS IS NOT COMPLETELY UNDERSTOOD BUT IS PROBABLY RELATED TO AN INABILITY OF THE NON-VIABLE CELLS TO MAINTAIN THEIR NORMALLY LOW INTRACELLULAR CONCENTRATION OF CALCIUM. ANOTHER POTENTIAL CONDITION THAT MAY LEAD TO RE-INTERVENTION IS PATIENT PROSTHESIS MISMATCH AND/OR UNDER-EXPANDED VALVES DUE TO THV RESTRICTION FROM THE EXISTING VALVE FRAME. INCORRECT BIOPROSTHETIC VALVE SIZING, AND INCOMPLETE FRAME EXPANSION, CAN CONTRIBUTE TO VALVE MIGRATION. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THV/TVT REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR QUARTER 1 2021 DATA EXTRACT FOR MITRAL DEATHS FOR THE SAPIEN 3 ULTRA VALVE. THIS REPORT SUMMARIZES 1 MITRAL VALVE REINTERVENTION FOR THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867153 EDWARDS SAPIEN 3 ULTRA HEART VALVE PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES LLC 9750TFX26 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death