BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE

    MDR report key: 10891728 · Received November 24, 2020

    Report

    Report Number
    2015691-2020-14648
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    October 26, 2020
    Report Date
    October 26, 2020
    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

    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 SUMMARIZES <NOE> 26 </NOE> EVENTS OF AORTIC VALVE RE-INTERVENTION SERIOUS INJURY EVENTS FOR THE SAPIEN 3 IN THE AORTIC POSITION FOR (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: E2016006, THIS REPORT SUMMARIZES 26 AORTIC VALVE RE-INTERVENTION SERIOUS INJURY EVENTS FOR THE SAPIEN 3 FOR (B)(6) 2020 IN THE AORTIC POSITION. THE ¿TIME TO EVENT¿ (TTE, IN DAYS) FOR THIS EVENT WAS 92.19. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE ARE: (B)(4). AORTIC 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 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. 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. THE MECHANISM BEHIND WORSENING OR LATE PVL IS NOT WELL UNDERSTOOD BUT MAY BE RELATED TO CARDIAC REMODELING. ACCORDING TO LITERATURE REVIEW, VALVE MIGRATION RESULTS WHEN FORCES ACTING ON THE TRANSCATHETER HEART VALVE (THV) OVERCOME THE STRENGTH OF ATTACHMENT OF THE VALVE TO THE AORTIC WALL. STENT VALVES ARE SUBJECTED TO ANTEGRADE EJECTION FORCES DURING SYSTOLE. LESS-THAN-SEVERE AND NON-UNIFORMLY DISTRIBUTED CALCIFICATION OF THE NATIVE LEAFLETS, INCORRECT BIOPROSTHETIC VALVE SIZING, AND INCOMPLETE FRAME EXPANSION, CAN CONTRIBUTE TO VALVE MIGRATION. ADDITIONALLY, RESIDUAL OVERHANGING LEAFLETS CAN EXERT DOWNWARDS FORCE DURING DIASTOLE, CAUSING MIGRATION OF THE THV TOWARDS THE LEFT VENTRICLE. 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 AUGUST 2020 DATA EXTRACT FOR AORTIC SERIOUS INJURY EVENTS FOR THE SAPIEN 3 VALVE. THIS REPORT SUMMARIZES 26 AORTIC VALVE RE-INTERVENTION SERIOUS INJURY EVENTS FOR THE SAPIEN 3 FOR AUGUST 2020. THE AGE RANGE FOR THESE EVENTS IS FROM 48 TO 90. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 20 MALES AND 6 FEMALES. AUGUST 2020 DATA EXTRACT INCLUDES DATA PROVIDED BY ACC FOR 2020 Q1 (JANUARY 1 ¿ MARCH 31, 2020).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361909 EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY NPT EDWARDS LIFESCIENCES 9600TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention