BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 24402337 · Received February 20, 2026

    Report

    Report Number
    2015691-2026-11277
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    February 1, 2014
    Report Date
    April 1, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER ADMINISTRATIVE REVIEW, THE REPORT OF THREE PATIENTS WHO UNDERWENT SURGICAL AORTIC VALVE REPLACEMENT DUE TO HEMODYNAMIC VALVE DETERIORATION (HVD) WAS SEPARATED FROM RELATED REPORT NUMBER 2015691 2026 11146 MOVED TO THIS REPORT. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM FEBRUARY 2014 AND JUNE 2022. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (1 FEBRUARY 2014) WAS USED AS THE OCCURRENCE DATE. IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, SECTIONS D1 AND D4 OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBER ASSOCIATED WITH AN EDWARDS SAPIEN 3 AND SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE IS P140031. LITERATURE REFERENCE: ANGELLOTTI, D., ELAMIN, N., FERRO, C., TOMII, D., LANZ, J., STORTECKY, S., ... & PILGRIM, T. (2025). REAL-TIME FLUOROSCOPIC ASSESSMENT OF UNDEREXPANSION PREDICTS HEMODYNAMIC VALVE DETERIORATION FOLLOWING TAVR WITH BALLOON-EXPANDABLE DEVICE. CARDIOVASCULAR INTERVENTIONS, 18(24), 3024-3035. INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED FOR CORRECTION AND ADDITIONAL INFORMATION BASED ON THE ENGINEER EVALUATION. THE FOLLOWING SECTIONS OF THIS REPORT HAVE BEEN UPDATED: CORRECTED H6 TYPE OF INVESTIGATION, CORRECTED H6 INVESTIGATION FINDINGS, AND CORRECTED INVESTIGATION CONCLUSIONS. 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. DUE TO THE UNAVAILABILITY OF THE COMPLAINT DEVICE, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL INSPECTION, FUNCTIONAL TESTING, OR DIMENSIONAL ANALYSIS. IMAGERY WAS PROVIDED IN THE ARTICLE; HOWEVER, IT WAS NOT RELEVANT TO THE COMPLAINT EVENT. 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 STRUCTURAL VALVE DEGENERATION WAS CONFIRMED BASED ON AVAILABLE INFORMATION TO DATE. DURING THE MANUFACTURING PROCESS, ALL SAPIEN 3/ 3 ULTRA 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. 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 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 ARTICLE, THE SELECTED PATIENT'S POPULATION HAD VAST COMORBIDITIES (I.E. HYPERTENSION, DIABETES, DYSLIPIDEMIA, HEMODIALYSIS, CORONARY ARTERY DISEASE, PERIPHERAL ARTERY DISEASE, COPD, ETC.), WHICH ARE KNOWN FACTORS THAT MAY INCREASE THE RISK FOR VALVE DEGENERATION, RESULTING IN REGURGITATION AND INCREASED GRADIENTS AS REPORTED. IN ADDITION, PER ARTICLE "THE RISK FOR HVD GRADUALLY INCREASED WITH INCREASING DEGREE OF UNDEREXPANSION (SUBDISTRIBUTION HR: 1.94 PER 5% INCREASE; 95% CI: 1.42-2.79), WITH CONSISTENT FINDINGS ACROSS ALL VALVE SIZES". AN UNDER-EXPANDED TRANSCATHETER HEART VALVE (THV) CONTRIBUTES TO EARLY STRUCTURAL VALVE DEGENERATION (SVD) PRIMARILY BY CREATING A NON-CIRCULAR, DISTORTED STENT FRAME THAT INDUCES ABNORMAL HEMODYNAMIC STRESS AND INCREASED MECHANICAL STRAIN ON THE LEAFLETS. WHEN THE STENT FAILS TO ACHIEVE FULL EXPANSION, IT LEADS TO IMPAIRED LEAFLET KINEMATICS, RESULTING IN "PIN-WHEELING" (THE INWARD FOLDING OF THE LEAFLETS) DURING DIASTOLE. THIS DISTORTION, COMBINED WITH REDUCED BLOOD FLOW VELOCITY AND INCREASED STASIS IN THE NEO-SINUS REGION, SIGNIFICANTLY ACCELERATES LEAFLET THROMBOSIS (HALT) AND SUBSEQUENT THICKENING. FURTHERMORE, THE NON-CIRCULAR, ELLIPTICAL SHAPE FORCES THE COMMISSURES TO BEAR HIGHER TENSILE STRESS, WHICH ACCELERATES THE FATIGUE-INDUCED CALCIFICATION PROCESS, RESULTING IN INCREASED GRADIENTS OR REGURGITATION. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURE FACTORS (UNDER EXPANDED THV) AND/OR PATIENT FACTORS (PRE-EXISTING COMORBIDITIES) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. HOWEVER, A DEFINITIVE ROOT CAUSE WAS UNABLE TO 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. SINCE NO EDWARDS PRODUCT DEFECTS OR LABELING DEFICIENCIES WERE IDENTIFIED, NO CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED.

    Description of Event or Problem · 0

    THROUGH REVIEW OF THE PUBLISHED MEDICAL ARTICLE "REAL-TIME FLUOROSCOPIC ASSESSMENT OF UNDEREXPANSION PREDICTS HEMODYNAMIC VALVE DETERIORATION FOLLOWING TAVR WITH BALLOON EXPANDABLE DEVICE" BY CORRESPONDING AUTHOR DR. DOMENICO ANGELLOTTI, AN EVENT INVOLVING EDWARDS TRANSCATHETER HEART VALVES WAS IDENTIFIED. ACCORDING TO THE ARTICLE, THREE PATIENTS WHO HAD UNDERGONE TRANSCATHETER AORTIC VALVE REPLACEMENT WITH 23 MM, 26 MM, OR 29 MM SAPIEN 3 OR SAPIEN 3 ULTRA VALVES IMPLANTED IN THE AORTIC POSITION EXPERIENCED HEMODYNAMIC VALVE DETERIORATION (HVD) WITHIN FIVE YEARS FOLLOWING THEIR PROCEDURES. THE REPORTED HVD WAS ASSOCIATED WITH INCREASED TRANSPROSTHETIC GRADIENTS, SIGNIFICANT INTRAPROSTHETIC REGURGITATION, OR A COMBINATION OF THESE MECHANISMS. THE THREE PATIENTS SUBSEQUENTLY UNDERWENT SURGICAL AORTIC VALVE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460196 SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention