BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 6851670 · Received September 8, 2017

    Report

    Report Number
    2015691-2017-02826
    Event Type
    Injury
    Date Received
    September 8, 2017
    Date of Event
    August 17, 2017
    Report Date
    August 17, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, PARAVALVULAR LEAK (PVL) IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. PARAVALVULAR LEAK REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE STRUCTURE OF THE IMPLANTED VALVE AND THE CARDIAC TISSUE, AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE. SOME PVL IS NOT UNCOMMON POST DEPLOYMENT. MANY CASES ARE MILD TO MODERATE, AND EITHER RESOLVE OVER TIME OR DO NOT CAUSE SYMPTOMS. OTHERS MAY BE MORE CLINICALLY SIGNIFICANT AND REQUIRE INTERVENTION. THE MECHANISM BEHIND WORSENING OR LATE PVL IS NOT WELL UNDERSTOOD BUT MAY BE RELATED TO CARDIAC REMODELING. IN THIS CASE, THE CAUSE OF THE WORSENING PVL IS UNKNOWN, AS INITIAL PROCEDURE DETAILS WERE NOT PROVIDE. HOWEVER, COULD BE RELATED TO CARDIAC REMODELING. 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

    AS REPORTED BY FIELD CLINICAL SPECIALIST (FCS), A SAPIEN WAS IMPLANTED WITHIN A FAILED NON-EDWARDS SURGICAL VALVE IN 2014 DUE TO STENOSIS AND REGURGITATION. APPROXIMATELY 3 YEARS LATER, POST SAPIEN PLACEMENT, THE PATIENT CAME BACK WITH PVL (3 JETS OF REGURGITATION BETWEEN THE SAPIEN STENT FRAME AND THE EXISTING MOSAIC VALVE SEWING RING). A 26MM S3 VALVE WAS IMPLANTED WITHIN THE SAPIEN VALVE. THE PROCEDURE WAS SUCCESSFUL WITH REMOVEMENT OF THE PVL. PER REPORT, THE 26MM SAPIEN VALVULAR AND LEAFLET FUNCTION WAS ACCEPTABLE AT TIME OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632300 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention