BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE

    MDR report key: 24392798 · Received February 19, 2026

    Report

    Report Number
    2015691-2026-11247
    Event Type
    Injury
    Date Received
    February 19, 2026
    Date of Event
    June 12, 2025
    Report Date
    February 19, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE INSTRUCTIONS FOR USE (IFU), ARRHYTHMIAS AND CONDUCTION SYSTEM DEFECTS WHICH MAY OR MAY NOT REQUIRE A PERMANENT PACEMAKER IMPLANTATION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BALLOON VALVULOPLASTY, THE USE OF LOCAL AND/OR GENERAL ANESTHESIA, BIOPROSTHETIC HEART VALVES, AND THE OVERALL TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE. ACCORDING TO THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC) GUIDELINES, THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE AORTIC VALVE COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE MAY EXPLAIN THESE COMPLICATIONS OF THE TVR PROCEDURE. ACCORDING TO THE LITERATURE REVIEW, AND AS DOCUMENTED IN EW CLINICAL TECHNICAL SUMMARY FOR COMPLAINTS, CONDUCTION DISTURBANCES/ HEART BLOCK, ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER TVR ARE ASSOCIATED WITH MANY PATIENT RELATED AND PROCEDURAL RELATED FACTORS, INCLUDING PREOPERATIVE COMORBID STATUS, THE DEGREE, AND BULKINESS OF ANNULAR CALCIFICATION, INTERVENTRICULAR SEPTAL THICKNESS, HISTORY OF ELECTROCARDIOGRAM ABNORMALITIES, THE DEPTH OF PROSTHESIS IMPLANTATION, AND THE PROFILE OF THE IMPLANTED PROSTHESIS. UNLIKE CONVENTIONAL AORTIC VALVE REPLACEMENT (AVR), WHERE THERE MAY BE LOCALIZED TRAUMA DUE TO DECALCIFICATION OF THE ANNULUS AND SUTURE PLACEMENT IN THE PROXIMITY OF THE ATRIOVENTRICULAR (AV) NODE OR THE BUNDLES, THE TRANSCATHETER HEART VALVE MAY CAUSE CONDUCTION ABNORMALITIES THROUGH MECHANICAL IMPINGEMENT OF THE CONDUCTION SYSTEM BY THE PROSTHESIS. THE MECHANISMS OF THE DEVELOPMENT OF HEART BLOCK AFTER TVR ARE WELL DOCUMENTED AND DESCRIBED IN THE LITERATURE. IT IS ALSO DOCUMENTED THAT PRE-EXISTING HEART BLOCK IS COMMON IN PATIENTS UNDERGOING THV OR SURGICAL AVR AND ANOTHER 4-6 % WILL DEVELOP POSTOPERATIVE HEART BLOCK, POTENTIALLY REQUIRING A PERMANENT PACEMAKER. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS ARE INCONCLUSIVE DUE TO THE LIMITED INFORMATION PROVIDED. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. 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. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME AT THIS TIME.

    Description of Event or Problem · 0

    MAULER-WITTWER S, PINTO B, HAGERMANN A, GIANNAKOPOULOS G, NOBLE S. EMERGENT REDO TRANSCATHETER AORTIC VALVE IMPLANTATION IN A NONAGENARIAN PATIENT WITH MULTIPLE ORGAN FAILURE. CJC OPEN. 2025 SEP 1;7(11):1535-1537. DOI: 10.1016/J.CJCO.2025.08.014. PMID: 41425783; PMCID: PMC12713185. AS REPORTED THROUGH LITERATURE PUBLICATION, THE PATIENT UNDERWENT A TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 26MM SAPIEN 3 ULTRA (S3U) VALVE IN A PRE-EXISTING NON-EDWARDS VALVE WITHIN ANOTHER NON-EDWARDS VALVE. APPROXIMATELY 7 YEARS POST TAVR, THE PATIENT SHOWED VALVE DYSFUNCTION WITH SEVERE AORTIC REGURGITATION, AND DEVELOPED MULTIPLE ORGAN FAILURE AND ACUTE RESPIRATORY DISTRESS. CONSEQUENTLY, AN URGENT VALVE-IN-VALVE WAS PERFORMED, IMPLANTING A SECOND 26MM S3U VALVE WITHIN THE OTHER PRE-EXISTING VALVES. BEFORE THE PROCEDURE, THE PATIENT WAS INTUBATED DUE TO THE RESPIRATORY DISTRESS. DURING THE PROCEDURE, SOME DIFFICULTIES WERE ENCOUNTERED WHEN CROSSING THE TRANSCATHETER HEART VALVE WITH THE PIGTAIL CATHETER (WITHOUT WIRE), AND A REGULAR WIRE WAS FINALLY NEEDED. THE VALVE WAS SUCCESSFULLY IMPLANTED AT NODE 4 WITHOUT CONTRAST MEDIA. THE PATIENT WAS THEN EXTUBATED AND ADMITTED TO AN INTERMEDIATE CARE UNIT WHERE DOBUTAMINE INFUSION AND NON-INVASIVE VENTILATION FOR 48 HOURS WERE PROVIDED. ADDITIONALLY, THE EVOLUTION WAS SLOWLY FAVORABLE, WITH CORRECTION OF THE LABORATORY TEST AND SYMPTOM IMPROVEMENT (MEAN GRADIENT 8MMHG AND NO AORTIC REGURGITATION). ON POSTOPERATIVE DAY 2, THE PATIENT SUFFERED A COMPLETE ATRIOVENTRICULAR BLOCK, REQUIRING A PERMANENT PACEMAKER IMPLANTATION. THE PATIENT WAS DISCHARGED 7 DAYS LATER TO A REHABILITATION CENTER, AND WAS SUBSEQUENTLY DISCHARGED HOME ANOTHER 2 WEEKS AFTER IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335604 EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention