BEUDAMED
    FDA Adverse Event Death Summary report: Y

    EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE

    MDR report key: 18280127 · Received December 6, 2023

    Report

    Report Number
    2015691-2023-18069
    Event Type
    Death
    Date Received
    December 6, 2023
    Date of Event
    October 1, 2023
    Report Date
    April 10, 2025
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT PROVIDES DATA FROM THV/TVT REGISTRY EXEMPTION NUMBER (B)(4) AND SUMMARIZES 1 REINTERVENTION - AORTIC VALVE DEATH EVENT FOR THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE IN THE AORTIC POSITION. THE "TIME TO EVENT" (TTE, IN DAYS) FOR THIS EVENT WAS 9.0. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE ARE: (B)(4). INTRA-PROCEDURAL AORTIC VALVE RE-INTERVENTION WILL TYPICALLY RESULT FROM VALVE MALPOSITION OR REGURGITATION (PVL OR CENTRAL, INCLUDING LEAFLET RESTRICTION). THESE CONDITIONS ARE KNOWN POTENTIAL RISKS ASSOCIATED WITH THE USE OF THE THV, DELIVERY SYSTEM, AND/OR ACCESSORIES. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO AORTIC MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMALLY OR BULKY/SEVERELY CALCIFIED AORTIC LEAFLETS, PRESERVED EJECTION FRACTION, SIGNIFICANT MITRAL ANNULAR CALCIFICATION (MAC), LOSS OF PACING CAPTURE, RAPID DEPLOYMENT, RELEASE OF STORED TENSION DURING DEPLOYMENT, AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. DEPLOYMENT OF THE SAPIEN VALVE TOO AORTIC HAS THE POTENTIAL TO CONTRIBUTE TO SUBOPTIMAL COAPTATION OF THE SAPIEN VALVE LEAFLETS AND CAUSE CENTRAL AORTIC INSUFFICIENCY; IT CAN OBSTRUCT THE CORONARY OSTIA; AND LEAD TO EMBOLIZATION OF THE PROSTHESIS INTO THE ASCENDING AORTA. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE THV. TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICE AT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR TO THE PLACEMENT AND FIXATION OF THE DEVICE. OPERATORS ARE ALSO INSTRUCTED TO USE FLUOROSCOPY AS THE PRIMARY METHOD OF VISUALIZATION FOR POSITIONING AND DEPLOYMENT. IN PATIENTS WITH HIGH-RISK ANATOMICAL FEATURES FOR AORTIC MALPOSITION (I.E., MINIMAL LEAFLET CALCIFICATION, SEVERE SEPTAL HYPERTROPHY), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. AORTIC VALVE RE-INTERVENTION IN THE FOLLOW-UP PERIOD (IN THE ABSENCE OF PROSTHETIC CARDIAC VALVE THROMBOSIS) WILL TYPICALLY RESULT FROM ON-GOING OR WORSENING REGURGITATION, VALVE DEGENERATION RELATED TO THE FORMATION OF CALCIFICATION OR PANNUS, OR VALVE MIGRATION. THESE EVENTS ARE IDENTIFIED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU) AS POTENTIAL RISKS ASSOCIATED WITH THE USE OF THE THV. REGURGITATION 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. REGURGITATION 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. CALCIFICATION IS A WELL-RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISM OF CALCIFICATION OF BIOMATERIALS IS NOT COMPLETELY UNDERSTOOD BUT IS PROBABLY RELATED TO AN INABILITY OF THE NON-VIABLE CELLS TO MAINTAIN THEIR NORMALLY LOW INTRACELLULAR CONCENTRATION OF CALCIUM. THE MECHANISM BEHIND WORSENING OR LATE PVL IS NOT WELL UNDERSTOOD BUT MAY BE RELATED TO CARDIAC REMODELING. ACCORDING TO LITERATURE REVIEW, VALVE MIGRATION RESULTS WHEN FORCES ACTING ON THE TRANSCATHETER HEART VALVE (THV) OVERCOME THE STRENGTH OF ATTACHMENT OF THE VALVE TO THE AORTIC WALL. STENT VALVES ARE SUBJECTED TO ANTEGRADE EJECTION FORCES DURING SYSTOLE. LESS-THAN-SEVERE AND NON-UNIFORMLY DISTRIBUTED CALCIFICATION OF THE NATIVE LEAFLETS, INCORRECT BIOPROSTHETIC VALVE SIZING, AND INCOMPLETE FRAME EXPANSION CAN CONTRIBUTE TO VALVE MIGRATION. ADDITIONALLY, RESIDUAL OVERHANGING LEAFLETS CAN EXERT DOWNWARDS FORCE DURING DIASTOLE, CAUSING MIGRATION OF THE THV TOWARDS THE LEFT VENTRICLE. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. SPECIFIC CLINICAL AND PROCEDURAL DETAILS ARE NOT AVAILABLE TO DETERMINE POTENTIAL CONTRIBUTING FACTORS TO THE EVENT, OR IF THE EVENT IS RELATED TO AN EDWARDS DEVICE. 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 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 · 0

    THIS SUPPLEMENTAL MDR CORRECTS SECTION C - COMBINATION DEVICE AND SECTION G4 CHECK BOX FOR COMBINATION PRODUCT. DURING REVIEW OF PREVIOUS SUBMISSIONS, IT WAS OBSERVED THAT THE COMBINATION DEVICE FIELD SECTION G4 WAS MARKED AS TRUE BY THE SYSTEM BECAUSE THE FIELD IN SECTION C WAS LEFT BLANK WHEN THE SUBMISSION WAS INITIALLY POPULATED. THE EW DEVICES SUBMITTED UNDER THIS MANUFACTURING REPORT ARE NOT CONSIDERED COMBINATION DEVICES.

    Description of Event or Problem · 0

    THV/TVT REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR QUARTER 4 2023 DATA EXTRACT FOR AORTIC DEATH EVENTS FOR THE SAPIEN 3 ULTRA VALVE. THIS REPORT SUMMARIZES 1 REINTERVENTION - AORTIC VALVE DEATH EVENT FOR THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE. THE AGE RANGE FOR THESE EVENTS IS 62-89 YEARS. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 1 MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197313 EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES LLC 9750TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown Death