BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 6353065 · Received February 23, 2017

    Report

    Report Number
    2015691-2017-00470
    Event Type
    Malfunction
    Date Received
    February 23, 2017
    Date of Event
    February 8, 2017
    Report Date
    February 8, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TORN LEAFLET OR INCREASED GRADIENT 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 DEGENERATION. 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. IN THIS CASE, THE VALVE WAS REPORTED TO BE DEGENERATED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COULD BE DUE TO EARLY CALCIFICATION OF THE LEAFLETS, HOST TISSUE OVERGROWTH OR IN RARE CASES, A NONFUNCTIONING LEAFLET. IF ADDITIONAL INFORMATION OR IMAGING IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. 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, AS LIMITED INFORMATION WAS PROVIDED, THERE ARE NO KNOWN RISK FACTORS THAT COULD HAVE CONTRIBUTED TO THE EVENT (END-STAGE RENAL INSUFFICIENCY, DISORDER OF CALCIUM METABOLISM). THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. 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 BY OUR AFFILIATES IN (B)(6), SIX YEARS POST IMPLANT OF THE 26MM SAPIEN XT IN THE AORTIC POSITION, THE VALVE HAD DEGENERATED. A VALVE-IN-VALVE PROCEDURE WAS REQUIRED, AS A SAPIEN 3 WAS PLACED. THE END RESULT WAS GOOD, NO PATIENT PROBLEMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136225 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention