BEUDAMED
    FDA Adverse Event Death Summary report: Y

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 11979767 · Received June 10, 2021

    Report

    Report Number
    2015691-2021-03481
    Event Type
    Death
    Date Received
    June 10, 2021
    Date of Event
    January 1, 2021
    Report Date
    June 10, 2021
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    NPU
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT PROVIDES DATA FROM THV/TVT REGISTRY DATA EXEMPTION NUMBER E2016006 AND SUMMARIZES 3 UNPLANNED OTHER CARDIAC SURGERY OR INTERVENTION EVENTS FOR THE SAPIEN 3 VALVE IN THE MITRAL POSITION. THE TIME TO EVENT [TTE IN DAYS] FOR THIS EVENT WAS 3.0. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE ARE: (B)(4). THE INSTRUCTIONS FOR USE (IFU) LIST REOPERATION, INCLUDING EMERGENCY CARDIAC SURGERY, AS ADDITIONAL POTENTIAL RISKS ASSOCIATED WITH THE USE OF THE THV, DELIVERY SYSTEM, AND/OR ACCESSORIES. THIS EVENT TYPE (UNPLANNED OTHER CARDIAC SURGERY OR INTERVENTION E031) IS DEFINED AS: THE PATIENT SUBSEQUENTLY UNDERWENT OTHER TYPES OF CARDIAC SURGERY OR CATH LAB INTERVENTIONS (NOT OTHERWISE SPECIFIED) THAT WAS UNPLANNED. THIS COULD INCLUDE REOPERATION FOR DAMAGE TO ADJACENT STRUCTURES, OR POTENTIALLY VALVE EXPLANT RELATED TO EMBOLIZATION, OR OTHER EVENT TYPES. CARDIOVASCULAR INJURY, INCLUDING PERFORATION OR DISSECTION OF VALVULAR STRUCTURES AND VALVE EMBOLIZATION REQUIRING INTERVENTION ARE KNOWN POTENTIAL COMPLICATIONS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU). PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVES (THV). TRAINING INCLUDES PROPER GUIDEWIRE POSITIONING, AND CAREFUL MANIPULATION OF DEVICES. PER THE THV TA TRAINING MANUALS, AFTER GAINING LV ACCESS WITH THE 0.035 SOFT GUIDEWIRE, THE WIRE SHOULD BE JIGGLED UNDER TEE IMAGING OF THE MITRAL VALVE. AN INCREASE IN MR SUGGESTS WIRE ENTANGLEMENT IN THE MITRAL SUBVALVULAR APPARATUS. IF ENTANGLEMENT IS SUSPECTED, THE GUIDEWIRE SHOULD BE COMPLETELY REMOVED FROM THE VENTRICLE; THE OPERATOR SHOULD CHANGE DIRECTION OF THE NEEDLE AND REINSERT THE GUIDEWIRE INTO THE VENTRICLE, CHECKING AGAIN FOR WIRE ENTANGLEMENT. THE TF TRAINING MANUAL ALSO PROVIDES GUIDANCE FOR VALVE CROSSING AND WIRE EXCHANGE: EXCHANGE 0.035 AMPLATZ EXTRASTIFF WIRE WITH PRESHAPED DISTAL END IN LEFT VENTRICLE. ENSURE THE GUIDE CATHETER IS ADVANCED UPON WIRE EXCHANGE TO ENSURE EXCHANGE WIRE DOES NOT GET CAUGHT IN THE MITRAL CHORDAE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VENTRICULAR EMBOLIZATION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, RAPID DEPLOYMENT, RELEASE OF STORED TENSION DURING DEPLOYMENT, AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. 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 SAPIEN 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 THIS CASE, SPECIFIC PROCEDURAL DETAILS ARE NOT AVAILABLE TO DETERMINE POTENTIAL CONTRIBUTING FACTORS, 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 AT THIS TIME.

    Description of Event or Problem · 1

    THV/TVT REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR Q1 2021 DATA EXTRACT FOR MITRAL DEATH FOR THE SAPIEN 3 VALVE. THIS REPORT SUMMARIZES 3 UNPLANNED OTHER CARDIAC SURGERY OR INTERVENTION EVENTS FOR THE SAPIEN 3 VALVE. THE AGE RANGE FOR THESE EVENTS IS FROM 61 TO 73. THE BREAKDOWN FOR GENDER IS 3 FEMALES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873327 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES LLC 9600TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death