BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE

    MDR report key: 11980191 · Received June 10, 2021

    Report

    Report Number
    2015691-2021-03500
    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
    NPT
    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

    EXEMPTION NUMBER E2016006. THIS REPORT PROVIDES DATA FROM (B)(6) REGISTRY EXEMPTION NUMBER E2016006 AND SUMMARIZES 1 EVENT OF DEVICE MIGRATION DEATH EVENT FOR THE SAPIEN 3 ULTRA IN THE AORTIC POSITION. THE 'TIME TO EVENT' (TTE, IN DAYS) FOR THIS EVENT WAS 0.00. 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 TRANSCATHETER AORTIC VALVE REPLACEMENT. 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. THE EDWARDS THV PATIENT SCREENING MANUAL ADVISES THE OPERATOR ON PRE-PROCEDURE ASSESSMENT OF THE AORTIC VALVE AND ROOT, TAKING INTO CONSIDERATION THE DEGREE AND DISTRIBUTION OF NATIVE LEAFLET CALCIFICATION. THE PROCEDURAL DIDACTIC INSTRUCTS 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 TRANSCATHETER HEART VALVE (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 REPORT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870119 EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES LLC SAPIEN 3 ULTRA VALVE UNKNOWN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death