BEUDAMED
    FDA Adverse Event Death Summary report: Y

    EDWARDS TRANSFEMORAL DELIVERY SYSTEM UNKNOWN

    MDR report key: 12194316 · Received July 19, 2021

    Report

    Report Number
    2015691-2021-04232
    Event Type
    Death
    Date Received
    July 19, 2021
    Date of Event
    December 3, 2020
    Report Date
    July 20, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    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 EXEMPTION NUMBER E2016006 AND SUMMARIZES 1 EVENT OF PERFORATION WITH OR W/O TAMPONADE DEATH FOR THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE IN THE MITRAL POSITION. THE ''TIME TO EVENT'' (TTE, IN DAYS) FOR THIS EVENT WAS 0.0. DUE TO THE LIMITED INFORMATION AND THE DATA RECEIVED, EDWARDS CANNOT CONFIRM WHICH DELIVERY SYSTEM WAS USED IN THIS CASE, THE ULTRA DELIVERY SYSTEM OR COMMANDER DELIVERY SYSTEM. THE UDI FOR BOTH DEVICES ARE REFERENCED BELOW. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS ULTRA DELIVERY SYSTEM ARE: (B)(4). THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS COMMANDER DELIVERY SYSTEM WITH ULTRA LOADER: (B)(4). PER THE INSTRUCTIONS FOR USE, CARDIOVASCULAR INJURIES, INCLUDING PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM, OR VALVULAR STRUCTURES, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY AND TRANSCATHETER HEART VALVE (THV) PROCEDURES. THERE ARE SEVERAL POTENTIAL ETIOLOGIES FOR CARDIAC PERFORATION DURING A THV PROCEDURE, INCLUDING PERFORATION BY THE GUIDEWIRE, THE DELIVERY SYSTEM, OR THE TRANSVENOUS PACER (TVP) LEAD. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE TRANSCATHETER HEART VALVES. TRAINING INCLUDES PROPER GUIDEWIRE POSITIONING, FIXATION OF THE TVP TO PREVENT VENTRICLE PERFORATION, AND CAREFUL MANIPULATION OF DEVICES. 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.

    Description of Event or Problem · 1

    THV/TVT REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR QUARTER 2 2021 DATA EXTRACT FOR MITRAL DEATHS FOR THE SAPIEN 3 ULTRA VALVE. THIS REPORT SUMMARIZES 1 PERFORATION WITH OR W/O TAMPONADE DEATH EVENTS FOR THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE. THE AGE RANGE FOR THESE EVENTS IS 76 YEARS. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 1 FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086384 EDWARDS TRANSFEMORAL DELIVERY SYSTEM UNKNOWN PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES TF DELIVERY SYSTEM UNKNOWN NI

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death