BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 7526552 · Received May 18, 2018

    Report

    Report Number
    2015691-2018-01891
    Event Type
    Injury
    Date Received
    May 18, 2018
    Date of Event
    May 1, 2018
    Report Date
    May 1, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4); SYSTEM UPDATES PENDING. RESULTS: KNOWN INHERENT RISK OF PROCEDURE. STENOSIS OF AN IMPLANTED VALVE MAY BE A MANIFESTATION OF STRUCTURAL VALVE DETERIORATION (SVD). THIS TERM REFERS TO CHANGES INTRINSIC TO THE VALVE, AND CAN INCLUDE FAILURE MODES SUCH AS WEAR, CALCIFICATION, LEAFLET TEAR, STENT CREEP, LEAFLET DISRUPTION, OR LEAFLET RETRACTION. THERE ARE CASES OF SVD THAT RESULT IN A COMBINATION OF REGURGITATION AND STENOSIS. IT MAY BE MILD AND NOT REQUIRE ANY INTERVENTION OR IT MAY BE MODERATE TO SEVERE. IN THESE CASES, IT CAUSES THE HEART TO WORK HARDER TO EJECT BLOOD FROM THE VENTRICLE. DEPENDING ON SEVERITY IT COULD BE AN INDICATION FOR VALVE REPLACEMENT OR MEDICAL INTERVENTION. A VERY COMMON FAILURE MODE IS TISSUE CALCIFICATION. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION. IN THIS CASE, THE ROOT CAUSE OF THE SAPIEN XT VALVE STENOSIS CANNOT BE DETERMINED. IN ADDITION TO THE MECHANISMS DESCRIBED ABOVE, PATIENT FACTORS AND CO-MORBIDITIES (RHEUMATIC HEART DISEASE) MAY HAVE CONTRIBUTED TO THE STENOSIS OF THE SAPIEN XT VALVE 3 YEARS POST IMPLANT IN AN EXISTING SURGICAL VALVE AND SUBSEQUENT SAPIEN 3 VALVE DEPLOYMENT DURING A VALVE IN VALVE PROCEDURE. 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.

    Description of Event or Problem · 1

    AS REPORTED, THREE YEARS POST IMPLANT OF A 23MM SAPIEN XT VALVE IN AN EXISTING SURGICAL MOSAIC AORTIC VALVE, THE PATIENT BECAME SYMPTOMATIC. STENOSIS OF THE VALVE AND INCREASED GRADIENTS WERE NOTED. A 26MM SAPIEN 3 VALVE WAS IMPLANTED IN THE SAPIEN XT VALVE. AT THE TIME OF THE REPORT, THE PATIENT WAS IN STABLE CONDITION. ALL VALVES REMAIN IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369265 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention