BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE / P140031

    MDR report key: 18845764 · Received March 6, 2024

    Report

    Report Number
    2015691-2024-01627
    Event Type
    Injury
    Date Received
    March 6, 2024
    Date of Event
    September 24, 2023
    Report Date
    March 6, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VALVE RELATED RE-ADMISSION IN THE FOLLOW-UP PERIOD IS LIKELY DUE TO REOCCURRENCE OF SYMPTOMS. THIS MAY RESULT FROM REGURGITATION (CENTRAL OR PVL) OR PROGRESSION OF THE PRE-EXISTING DISEASE PROCESS AND MAY RESULT IN HEART FAILURE. CAUSES OF HEART FAILURE CAN BE MULTI-FACTORIAL. PER THE INSTRUCTION FOR USE (IFU), HEART FAILURE, VALVE REGURGITATION, AND VALVE DEGENERATION INCLUDING STENOSIS ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. CONGESTIVE HEART FAILURE CAN HAVE MULTIPLE ETIOLOGIES AND IS OFTEN DUE TO THE PROGRESSION OF UNDERLYING DISEASE PROCESSES, INCLUDING CORONARY ARTERY DISEASE, UNCONTROLLED HYPERTENSION, MYOCARDIAL INFARCTION, CARDIOMYOPATHY, FLUID OVERLOAD, OR VALVULAR DYSFUNCTION. RISK FACTORS THAT INCREASE A PATIENT'S RISK OF SUFFERING FROM CHF INCLUDE OBESITY, ADVANCED AGE, AND A HISTORY OF SMOKING. REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO A NUMBER OF 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. THE MECHANISM BEHIND WORSENING OR LATE PVL IS NOT WELL UNDERSTOOD BUT MAY BE RELATED TO CARDIAC REMODELING. VALVE STENOSIS MAY RESULT IN SYMPTOMS SUCH AS SOB AND DECREASED EXERCISE TOLERANCE, WHICH MAY BE ACCOMPANIED BY AN INCREASED GRADIENT ACROSS THE VALVE. THIS COULD BE DUE TO EARLY CALCIFICATION OF THE LEAFLETS, HOST TISSUE OVERGROWTH, OR IN RARE CASES A NONFUNCTIONING LEAFLET. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. SPECIFIC CLINICAL AND PROCEDURAL DETAILS ARE NOT AVAILABLE TO DETERMINE POTENTIAL CONTRIBUTING FACTORS TO THE EVENT, OR IF THE EVENT IS RELATED TO AN EDWARDS DEVICE. 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    AS REPORTED THROUGH DATA RECEIVED THROUGH THE TVT REGISTRY, 407 DAYS POST IMPLANT OF A 20MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION VIA UNKNOWN APPROACH, THE PATIENT HAD AORTIC VALVE RELATED READMISSION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670252 EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE / P140031 AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750TFX20 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Other| R