BEUDAMED
    FDA Adverse Event Death Summary report: Y

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 11979678 · Received June 10, 2021

    Report

    Report Number
    2015691-2021-03476
    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 MITRAL VALVE REINTERVENTION FOR THE SAPIEN 3 VALVE IN THE MITRAL POSITION. THE TIME TO EVENT [TTE IN DAYS] FOR THIS EVENT WAS 111.33. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE ARE: (B)(4). INTRAPROCEDURAL AND IN HOSPITAL MITRAL VALVE REINTERVENTION 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 VALVE MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, CHARACTERISTICS OF THE PREEXISTING VALVE OR RING, LOSS OF PACING CAPTURE, RAPID DEPLOYMENT, RELEASE OF STORED TENSION DURING DEPLOYMENT, AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. VALVE MALPOSITION HAS THE POTENTIAL TO CONTRIBUTE TO SUBOPTIMAL COAPTATION OF THE THV VALVE LEAFLETS AND CAUSE CENTRAL AORTIC INSUFFICIENCY; IT CAN LEAD TO MIGRATION OR EMBOLIZATION OF THE PROSTHESIS. 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 THIS CASE, SPECIFIC PROCEDURAL DETAILS ARE NOT AVAILABLE TO DETERMINE POTENTIAL CONTRIBUTING FACTORS. 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.

    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 MITRAL VALVE REINTERVENTION EVENTS FOR THE SAPIEN 3 VALVE. THE AGE RANGE FOR THESE EVENTS IS FROM 71 TO 81. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 1 MALE AND 2 FEMALES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870415 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 78 YR Death