BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 23MM

    MDR report key: 7660646 · Received July 3, 2018

    Report

    Report Number
    2015691-2018-02610
    Event Type
    Injury
    Date Received
    July 3, 2018
    Date of Event
    June 13, 2018
    Report Date
    June 13, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    AN ADMINISTRATIVE REVIEW OF 3500A FORMS POSTED ON THE MAUDE DATABASE SHOWED THIS MANUFACTURER REPORT WAS SUBMITTED WITH THE INCORRECT (COMMON DEVICE NAME, PRODUCT CODE, PMA NUMBER, OR OTHER MISSED OR INCORRECT INFORMATION). A CORRECTION TO FIELDS D2 IS BEING SUBMITTED IN THIS SUPPLEMENTAL REPORT

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. 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. IN THIS CASE, THE CAUSE OF THE WORSENING CENTRAL LEAK IS UNKNOWN. DESPITE MULTIPLE FOLLOW UP ATTEMPTS, ADDITIONAL INFORMATION REQUESTED WAS NOT PROVIDED. HOWEVER, PER REPORT, IT IS POSSIBLE THAT THE S3 VALVE MAY NOT HAVE BEEN FULLY EXPANDED AND EQUILIBRIUM OF DIASTOLIC PRESSURES MAY HAVE CONTRIBUTED TO THE WORSENING CENTRAL REGURGITATION. 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

    APPROXIMATELY 8 MONTHS POST IMPLANTATION OF A 23 MM SAPIEN 3 VALVE IN THE PULMONIC POSITION INSIDE A PULMONARY CONDUIT, THE PATIENT PRESENTED WITH MODERATE - SEVERE CENTRAL INSUFFICIENCY. THE PATIENT SUCCESSFULLY UNDERWENT A VALVE IN VALVE PROCEDURE WITH A NON-EDWARDS TRANSCATHETER PULMONARY VALVE. THE PATIENT IS STABLE. AS REPORTED, AN INTRACARDIAC ECHO (ICE) WAS PERFORMED AND REVEALED NO PARAVALVULAR LEAK (PVL) BUT MODERATE-SEVERE CENTRAL LEAK. PER REPORT, 2 PERCEIVED ROOT CAUSES WERE DISCUSSED - THE 23 MM SAPIEN 3 VALVE WAS NOT FULLY EXPANDED (SIZE OF THE CONDUIT WAS UNKNOWN) AND EQUILIBRIUM OF DIASTOLIC PRESSURES. THE RIGHT VENTRICLE (RV) AND THE PULMONARY DIASTOLIC PRESSURES WERE PRETTY CLOSE IN PRESSURE. THE RV AND PULMONARY DID NOT HAVE ENOUGH PRESSURE DIFFERENCE TO ALLOW THE S3 VALVE TO CLOSE PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501835 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 23MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX23A
    501836 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 23MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention