BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 17967130 · Received October 19, 2023

    Report

    Report Number
    2015691-2023-16923
    Event Type
    Injury
    Date Received
    October 19, 2023
    Date of Event
    September 29, 2023
    Report Date
    October 19, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE INSTRUCTIONS FOR USE (IFU), PARAVALVULAR LEAK (PVL) IS A KNOWN 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, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED BY AN EDWARDS LIFSCIENCES AFFILIATE, APPROXIMATELY 8 YEARS POST IMPLANTATION OF A 23MM SAPIEN 3 XT VALVE IN THE AORTIC POSITION, A 23MM SAPIEN 3 ULTRA RESILIA VALVE WAS PLACED INSIDE THE VALVE DUE TO PARAVALVULAR LEAK (PVL). THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87035 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention