BEUDAMED
    FDA Adverse Event Death Summary report: Y

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 11980100 · Received June 10, 2021

    Report

    Report Number
    2015691-2021-03496
    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 (B)(6) REGISTRY DATA EXEMPTION NUMBER E2016006 AND SUMMARIZES 1 PERFORATION WITH OR W/O TAMPONADE EVENT FOR THE SAPIEN 3 VALVE IN THE MITRAL POSITION. THE TIME TO EVENT [TTE IN DAYS] FOR THIS EVENT WAS 0. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS COMMANDER DELIVERY SYSTEM ARE: (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. SUMMARY REPORTING.

    Description of Event or Problem · 1

    (B)(6) REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR Q1 2021 DATA EXTRACT FOR MITRAL DEATH FOR THE SAPIEN 3 VALVE. THIS REPORT SUMMARIZES 1 PERFORATION WITH OR W/O TAMPONADE EVENT FOR THE SAPIEN 3 VALVE. THE PATIENT AGE IS (B)(6). THE BREAKDOWN FOR GENDER IS 1 FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872712 EDWARDS COMMANDER DELIVERY SYSTEM PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES LLC COMMANDER DELIVERY SYSTEM UNKNOWN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death