BEUDAMED
    FDA Adverse Event Death Summary report: Y

    EDWARDS SAPIEN 3

    MDR report key: 10346046 · Received July 30, 2020

    Report

    Report Number
    2015691-2020-12854
    Event Type
    Death
    Date Received
    July 30, 2020
    Date of Event
    May 29, 2020
    Report Date
    July 27, 2020
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    NPT
    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 · 0

    SUPPLEMENTAL REPORT TO ADD NOE STATEMENT IN B5 SECTION, AND PROVIDE D5, AND H6 INFORMATION.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZE <NOE> 23 </NOE> EVENTS OF VALVE RELATED READMISSION DEATH EVENTS FOR THE SAPIEN 3 FOR (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016006, THIS REPORT SUMMARIZES 23 EVENTS OF VALVE RELATED READMISSION FOR THE SAPIEN 3 VALVE IN THE AORTIC POSITION. THE ¿TIME TO EVENT¿ (TTE, IN DAYS) FOR THIS EVENT WAS 112.08. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE ARE: (B)(4). 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 NON-FUNCTIONING LEAFLET. IN THIS CASE, SPECIFIC CLINICAL DETAILS ARE NOT AVAILABLE TO DETERMINE POTENTIAL CONTRIBUTING FACTORS TO THE EVENT. 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 DEATH EVENT SUBMISSION FOR (B)(6) 2020 DATA EXTRACT FOR AORTIC DEATH FOR THE SAPIEN 3 VALVE. THIS REPORT SUMMARIZES 23 EVENTS OF VALVE RELATED READMISSION DEATH EVENTS FOR THE SAPIEN 3 TRANSCATHETER HEART VALVE FOR (B)(6) 2020. THE AGE RANGE FOR THESE EVENTS IS FROM 66 TO 92. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 13 MALES AND 10 FEMALES. (B)(6) 2020 DATA EXTRACT INCLUDES DATA PROVIDED BY ACC FOR Q4 2019 (OCTOBER 1 ¿ DECEMBER 31).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808787 EDWARDS SAPIEN 3 AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES LLC 9600TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death