BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VLV (26MM)

    MDR report key: 10963229 · Received December 7, 2020

    Report

    Report Number
    2015691-2020-14915
    Event Type
    Injury
    Date Received
    December 7, 2020
    Date of Event
    November 12, 2020
    Report Date
    November 12, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IMAGE REVIEW WAS PERFORMED BY AN EDWARDS LIFESCIENCES PHYSICIAN PROCTOR. ECHOCARDIOGRAPHY PRE-TAVI PROCEDURE FOR VALVE IN VALVE WAS PROVIDED FOR REVIEW. ECHOCARDIOGRAPHY: IT WAS CONFIRMED THAT THE SAPIEN XT VALVE IN THE AORTIC POSITION WAS CALCIFIED WITH MILD REGURGITATION. THERE WAS SEVERE AORTIC STENOSIS, MEAN GRADIENT 49MMHG, AVA VMAX 0.65 CM2, AND AVA VTI 0.55 CM2. IMPRESSION: NO ROOT CAUSE IDENTIFIED FOR EARLY DEGENERATION. CALCIFIC DEGENERATION IS A COMMON CAUSE OF BIOPROSTHETIC HEART VALVE FAILURES. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS AND MECHANICAL STRESS.

    Additional Manufacturer Narrative · 0

    CALCIFICATION OF AN IMPLANTED VALVE MAY BE A MANIFESTATION OF STRUCTURAL VALVE DETERIORATION (SVD). 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. 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. 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. PER A TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES, CALCIFIC DEGENERATION IS A COMMON CAUSE OF BIOPROSTHETIC HEART VALVE FAILURES. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.), MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE, AND GLUTARALDEHYDE FIXATION OF TISSUE. OF THESE, THE FIXATION PROCESS IS A RELATIVELY MINOR CONTRIBUTOR TO CALCIFICATION FOR EDWARDS' TISSUE VALVES DUE TO SUBSEQUENT ANTI-CALCIFICATION TREATMENTS DURING MANUFACTURING. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT A BIOPROSTHESIS FROM CALCIFYING. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THESE ADVERSE EVENTS. BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE FOR THE VALVE CALCIFICATION AND ONE IMMOBILE LEAFLET DUE TO THICKENING COULD NOT BE CONFIRMED, BUT MAY BE RELATED TO THE PATIENT¿S 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. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATES IN (B)(6), APPROXIMATELY FIVE YEARS AND EIGHT MONTHS POST IMPLANT OF A 26MM SAPIEN XT VALVE IN THE AORTIC POSITION, THE VALVE APPEARED DEGENERATED WITH VALVE CALCIFICATION, AND ONE IMMOBILE LEAFLET DUE TO THICKENING. A 26MM SAPIEN 3 VALVE WAS IMPLANTED WITHIN THE PRE-EXISTING VALVE. THE PATIENT WAS STABLE POST PROCEDURE. AS PER MEDICAL OPINION, THE ROOT CAUSE OF THE CALCIFICATION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428104 EDWARDS SAPIEN XT TRANSCATHETER HEART VLV (26MM) AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention