BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE

    MDR report key: 24236772 · Received February 2, 2026

    Report

    Report Number
    2015691-2026-10731
    Event Type
    Injury
    Date Received
    February 2, 2026
    Date of Event
    January 12, 2026
    Report Date
    February 27, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103201338
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR CORRECTION AND TO INCLUDE ADDITIONAL INFORMATION FROM THE INVESTIGATION. THE FOLLOWING SECTIONS OF THIS REPORT HAVE BEEN CORRECTED/UPDATED: H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS) AND H11 (ADDITIONAL NARRATIVE/DATA). THE EVENTS REPORTED ARE ANTICIPATED IN THE RISK MANAGEMENT DOCUMENTATION FOR TRANSCATHETER HEART VALVE PROCEDURES. ADDITIONAL ASSESSMENT OF THE FAILURE MODES IS NOT REQUIRED AT THIS TIME. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. AS A RESULT, NO VISUAL INSPECTION, FUNCTIONAL TESTING, OR DIMENSIONAL ANALYSIS COULD BE PERFORMED. IN ADDITION, NO IMAGERY WAS PROVIDED FOR EVALUATION. THE INSTRUCTIONS FOR USE (IFU), AND TRAINING MANUALS HAVE BEEN REVIEWED. NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. THE COMPLAINT FOR VALVE STENOSIS AND VALVE LEAFLET MOTION RESTRICTION THAT REQUIRES AN INTERVENTION HAS BEEN CONFIRMED BASED ON THE INFORMATION AVAILABLE TO DATE. ANY UPDATES OR ADDITIONAL FINDINGS WILL BE SUBMITTED IN ACCORDANCE WITH FDA REPORTING REQUIREMENTS. DURING THE MANUFACTURING PROCESS, ALL SAPIEN 3 ULTRA RESILIA VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR PROPER COAPTATION UNDER PHYSIOLOGICAL BACKPRESSURE CONDITIONS PRIOR TO RELEASE FOR DISTRIBUTION. THEREFORE, IT IS HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION CONTRIBUTED TO THE EVENT. PER THE INSTRUCTION FOR USE (IFU), VALVE STENOSIS IS A POTENTIAL RISK ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. PER THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC), VALVE STENOSIS CAN RESULT FROM A NUMBER OF FACTORS, INCLUDING PANNUS, CALCIFICATION, SUPPORT STRUCTURE DEFORMATION (OUT-OF-ROUND CONFIGURATION), TRAUMA (CARDIA-PULMONARY RESUSCITATION, BLUNT CHEST TRAUMA), ENDOCARDITIS, PROSTHETIC VALVE THROMBOSIS, AND NATIVE LEAFLET PROLAPSE IMPEDING PROSTHETIC LEAFLET MOTION. VALVE STENOSIS MAY RESULT IN SYMPTOMS SUCH AS SHORTNESS OF BREATH AND DECREASED EXERCISE TOLERANCE, WHICH MAY BE ACCOMPANIED BY AN INCREASED GRADIENT ACROSS THE VALVE. THIS COULD BE DUE TO EARLY CALCIFICATION OF THE LEAFLETS, HOST TISSUE OVERGROWTH OR IN RARE CASES, A NON-FUNCTIONING LEAFLET. CALCIFICATION IS A WELL-RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. 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. 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. 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 SEVERITY IT COULD BE AN INDICATION FOR VALVE REPLACEMENT OR MEDICAL INTERVENTION. IN ADDITION, LEAFLET MOTION RESTRICTION, WHICH DEVELOPS PROGRESSIVELY OVER TIME, CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, LEAFLET THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. LEAFLET MOTION RESTRICTION MAY ALSO DEVELOP PROGRESSIVELY IF HOST FIBROTIC TISSUE, OR PANNUS, GROWS ONTO THE BIOPROSTHETIC VALVE. PANNUS, A CAUSE OF NONSTRUCTURAL DYSFUNCTION, MAY INTERFERE WITH FUNCTIONALITY OF THE DEVICE BY RESTRICTING THE LEAFLET MOTION LEADING TO ABNORMAL COAPTATION. IN THIS CASE, DUE TO LIMITED INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME; HOWEVER, THE REPORTED EVENT COULD BE RELATED TO THE MECHANISMS DESCRIBED ABOVE. 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. SINCE NO EDWARDS PRODUCT DEFECTS OR LABELING DEFICIENCIES WERE IDENTIFIED, NO CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 3 YEARS, 4 MONTHS, AND 6 DAYS AFTER THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA VALVE, THE PATIENT WAS BEING WORKED UP DUE TO SEVERE AORTIC STENOSIS. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED. FOLLOWING THE TAVR PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA VALVE, THE POST PROCEDURE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) DEMONSTRATED A PEAK VELOCITY (PV) OF 265 CM/SEC, A MEAN GRADIENT OF 16.4 MMHG, AN AORTIC VALVE VELOCITY-TIME INTEGRAL (VTI) AREA OF 2.1 CM2, AND A DIMENSIONLESS INDEX (DI) OF 0.38. APPROXIMATELY 3 YEARS, 2 MONTHS, AND 26 DAYS AFTER THE TAVR PROCEDURE, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) DEMONSTRATED A PV OF 375 CM/SEC, A MEAN GRADIENT OF 29.6 MMHG, AN AORTIC VALVE VTI AREA OF 0.6 CM2, AND A DI OF 0.18. APPROXIMATELY 3 YEARS, 3 MONTHS, AND 20 DAYS AFTER THE TAVR PROCEDURE, THE PATIENT REPORTED PROGRESSIVE EXERTIONAL SHORTNESS OF BREATH WITH A RECENT ECHOCARDIOGRAM SHOWING ELEVATED GRADIENTS. A TEE WAS COMPLETED WHICH REVEALED A FROZEN NON-CORONARY CUSP, AND RESTRICTED RIGHT AND LEFT CUSPS LEADING TO SEVERE STENOSIS. IT WAS RECOMMENDED THAT THE PATIENT BE SCHEDULED FOR A REPEAT TAVR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297130 EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750TFX26A 00690103201338

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention