BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 ULTRA HEART VALVE

    MDR report key: 11971412 · Received June 9, 2021

    Report

    Report Number
    2015691-2021-03394
    Event Type
    Death
    Date Received
    June 9, 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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS REPORT SUMMARIZES 2 DEVICE MIGRATION, MITRAL DEATH EVENTS FOR THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE.

    Additional Manufacturer Narrative · 1

    THIS REPORT PROVIDES DATA FROM (B)(6) REGISTRY EXEMPTION NUMBER E2016006 AND SUMMARIZES 3 DEVICE MIGRATION, MITRAL DEATH EVENTS, FOR THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE IN THE MITRAL POSITION. THE 'TIME TO EVENT' (TTE, IN DAYS) FOR THIS EVENT WAS 0. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE ARE: (B)(4). PER THE INSTRUCTIONS FOR USE, VALVE MIGRATION REQUIRING INTERVENTION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF TRANSCATHETER HEART VALVES. VALVE MIGRATION RESULTS WHEN FORCES ACTING ON THE THV OVERCOME THE STRENGTH OF ATTACHMENT OF THE VALVE TO THE SITE OF DEPLOYMENT. STENT VALVES ARE SUBJECTED TO ANTEGRADE EJECTION FORCES DURING SYSTOLE. INCORRECT BIOPROSTHETIC VALVE SIZING AND INCOMPLETE FRAME EXPANSION, CAN CONTRIBUTE TO VALVE MIGRATION. 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 SIZING, ALIGNMENT AND POSITIONING OF THE DEVICE ARE EMPHASIZED AS KEY FACTORS TO THE PLACEMENT AND FIXATION OF THE DEVICE. IN THIS CASE, SPECIFIC PROCEDURAL DETAILS ARE NOT AVAILABLE TO DETERMINE POTENTIAL CONTRIBUTING FACTORS TO THE EVENT. 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. SUMMARY REPORTING.

    Description of Event or Problem · 1

    (B)(6) REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR QUARTER 1 2021 DATA EXTRACT FOR MITRAL DEATHS FOR THE SAPIEN 3 ULTRA VALVE. THIS REPORT SUMMARIZES 3 DEVICE MIGRATION EVENTS FOR THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE. THE AGE RANGE FOR THESE EVENTS IS 75-83 YEARS. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 2 FEMALES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867648 EDWARDS SAPIEN 3 ULTRA HEART VALVE PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES LLC 9750TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death