BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE

    MDR report key: 24069103 · Received January 14, 2026

    Report

    Report Number
    2015691-2026-10404
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    December 23, 2025
    Report Date
    January 20, 2026
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED DUE TO ENGINEERING EVALUATION FINDINGS, SECTIONS G6, H2, H6: DEVICE CODES, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS AND H11 HAS BEEN ADDED. THE EVENT(S) REPORTED IS/ARE ANTICIPATED IN THE RISK MANAGEMENT DOCUMENTATION FOR TRANSCATHETER HEART VALVE PROCEDURES. ADDITIONAL ASSESSMENT OF THE FAILURE MODE(S) IS NOT REQUIRED AT THIS TIME. THE DEVICE WAS NOT RETURNED FOR EVALUATION. DUE TO THE UNAVAILABILITY OF THE COMPLAINT DEVICE, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL INSPECTION, FUNCTIONAL TESTING, OR DIMENSIONAL ANALYSIS. THROUGH EXTENSIVE COMPLAINT INVESTIGATIONS, STRUCTURAL VALVE DEGENERATION RELATED TO CALCIFICATION FOR THE SAPIENXT, S3, S3U, AND S3UR VALVES HAVE NOT BEEN ASSOCIATED WITH DEVICE MALFUNCTIONS OR MANUFACTURING NONCONFORMANCES. RATHER, THE ROOT CAUSE FOR THESE EVENTS HAVE HISTORICALLY BEEN DUE TO PATIENT FACTORS (AGE, DISEASE STATE, PATIENT CO-MORBIDITIES, AND/OR PHARMACOLOGICAL INTERVENTION). THE COMPLAINT FOR CALCIFICATION WAS CONFIRMED BASED ON MEDICAL RECORD. AS REPORTED, 'CT ON PERFORMED REVEALS TAVR WITH CALCIFICATION OF THE PROSTHETIC VALVE LEAFLETS.' AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (HYPERLIPIDEMIA) LIKELY CONTRIBUTED TO THE EVENT AS THE PATIENT HAD MEDICAL HISTORY OF HYPERLIPIDEMIA (HLN). THE PROCESS OF CALCIFICATION INVOLVES THE REACTION OF CALCIUM-CONTAINING EXTRACELLULAR FLUID WITH MEMBRANE-ASSOCIATED PHOSPHORUS, CAUSING CALCIFICATION OF THE CELLS. MANY PATIENT-RELATED FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION, AND CONSEQUENTLY, STRUCTURAL DEGENERATION OF THE THV. THESE FACTORS INCLUDE AGE, DISEASE STATE, PATIENT CO-MORBIDITIES, AND/OR PHARMACOLOGICAL INTERVENTION, SUCH AS BUT NOT LIMITED TO RENAL FAILURE, HEMODIALYSIS, HYPERCHOLESTEROLEMIA, HYPERLIPIDEMIA, HYPOTHYROIDISM, DIABETES MELLITUS, ETC. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    AS REPORTED FROM FCS, APPROXIMATELY 2 YEARS POST TAVR, THE PATIENT PRESENTS WITH A FAILED 23MM SAPIEN 3 ULTRA VALVE NOW PRESENTING WITH STENOSIS. ADDITIONAL INFORMATION WAS RECEIVED ON THE REPORTED ISSUE OF STENOSIS OF A PREVIOUSLY IMPLANTED TRANSCATHETER HEART VALVE (THV). IT IS UNKNOWN WHETHER INTERVENTION WILL BE REQUIRED. MEDICAL RECORDS WERE RECEIVED WITH MEDICAL HISTORY AND PLAN FOR THE PATIENT. AFTER A REVIEW OF THE MEDICAL RECORDS, A TTE PERFORMED SHOWED THE 23MM S3 IN THE AORTIC POSITION WAS FUNCTIONING "ABNORMALLY" WITH FINDINGS CONSISTENT WITH STENOSIS, MEAN GRADIENT 59MMHG, AVA 0.70CM2, NO AR NOR PVL. CT ON PERFORMED REVEALS TAVR WITH CALCIFICATION OF THE PROSTHETIC VALVE LEAFLETS. PLAN WAS FOR VIV VS. SURGICAL EXPLANT DISCUSSED WITH FAMILY. DEVICE INFORMATION AND EXACT IMPLANT DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130317 EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES LLC 9750TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention