BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 8502273 · Received April 10, 2019

    Report

    Report Number
    2015691-2019-01251
    Event Type
    Injury
    Date Received
    April 10, 2019
    Date of Event
    March 17, 2019
    Report Date
    March 21, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER MEDICAL RECORDS, APPROXIMATELY 4 YEARS AND 9 MONTHS POST TAVR WITH A 20MM S3 VALVE, THE PATIENT PRESENTED TO THE ED WITH ACUTE RESPIRATORY DISTRESS AND WAS ADMITTED FOR TREATMENT AND WORK-UP.  A TEE PERFORMED 3 DAYS AFTER ADMISSION REVEALED: SEVERELY THICKENED AND CALCIFIED TAVR LEAFLETS WITH SEVERELY RESTRICTED OPENING CONSISTENT WITH SEVERE AORTIC VALVE WITH DEGENERATIVE CHANGES OF TAVR VALVE ON IMAGES; MODERATE AORTIC REGURGITATION; AORTIC VALVE AREA OF 0.26 CM2, PEAK GRADIENT 89.5 MMHG AND MEAN GRADIENT OF 47.9 MMHG. A VALVE IN VALVE PROCEDURE WAS PERFORMED ON THE SAME DAY WITH A NON-EDWARDS VALVE.  THE PATIENT TOLERATED THE PROCEDURE WELL. DEVICE DEGENERATION IS A KNOWN POTENTIAL RISK ASSOCIATED WITH THE TAVR PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS A POTENTIAL ADVERSE EVENT.   STRUCTURAL VALVE DETERIORATION (SVD) MAY BE MANIFESTED AS STENOSIS WITH THICKENED LEAFLETS.  SVD 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.  SVD MAY BE MILD AND NOT REQUIRE ANY INTERVENTION OR IT MAY BE MODERATE TO SEVERE. IT CAN CAUSE THE HEART TO WORK HARDER TO EJECT BLOOD FROM THE VENTRICLE.  DEPENDING ON THE SEVERITY IT COULD BE AN INDICATION FOR VALVE REPLACEMENT OR MEDICAL INTERVENTION.  TISSUE CALCIFICATION IS A VERY COMMON FAILURE MODE.  THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT YET 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.  BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE FOR THE VALVE DEGENERATION APPROXIMATELY 5 YEARS POST VALVE IMPLANT COULD NOT BE DETERMINED, BUT MAY BE RELATED TO THE PATIENT¿S CO-MORBIDITIES AND/OR PRE-EXISTING VALVULAR DISEASE PROCESS.   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.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED FROM S3U CLINICAL TRIALS, APPROXIMATELY 4 YEARS AND 9 MONTHS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), THE PATIENT WAS ADMITTED WITH SHORTNESS OF BREATH (SOB) AND ECHOCARDIOGRAM SHOWED SEVERELY THICKENED AND CALCIFIED TAVR VALVE LEAFLETS WITH SEVERELY RESTRICTED OPENING, CONSISTENT WITH SEVERE AORTIC VALVE WITH DEGENERATIVE CHANGES OF TAVR VALVE.  THE PATIENT UNDERWENT SUCCESSFUL EMERGENT VALVE IN VALVE TAVR PROCEDURE.  ADDITIONAL DETAILS OF THE DEVICE (DEVICE MODEL AND SERIAL NUMBER) AND EVENT ARE NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292386 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX20A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention