BEUDAMED
    FDA Adverse Event Death Summary report: Y

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 14892478 · Received July 1, 2022

    Report

    Report Number
    2015691-2022-06579
    Event Type
    Death
    Date Received
    July 1, 2022
    Date of Event
    April 1, 2022
    Report Date
    July 26, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT PROVIDES DATA FROM THV/TVT REGISTRY EXEMPTION NUMBER E2016006 AND SUMMARIZES 5 AORTIC DISSECTION DEATH EVENTS FOR THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE IN THE AORTIC POSITION. THE ''TIME TO EVENT'' (TTE, IN DAYS) FOR THIS EVENT WAS 0.00. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS COMMANDER DELIVERY SYSTEM ARE: 00690103193930, 00690103193947, 00690103193954, 00690103193961. PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. ASCENDING AORTIC DISSECTION MAY OCCUR WHEN MULTIPLE ATTEMPTS ARE MADE TO CROSS THE STENOTIC NATIVE VALVE, AND/OR WHEN EXCESSIVE FORCE IS USED. AORTIC DISSECTION IN A DISTAL SECTION OF THE AORTA CAN OCCUR WITH DEVICE MANIPULATION AND NAVIGATION THROUGH ANATOMIC TORTUOSITY. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). THE THV TRAINING MANUALS PROVIDE GUIDANCE TO FACILITATE SAFE CROSSING OF THE NATIVE VALVE, INCLUDING CAMERA PROJECTIONS, HANDLING DURING ADVANCEMENT, AND TROUBLESHOOTING TECHNIQUES IF DIFFICULTY IS ENCOUNTERED. AS STATED, EXCESSIVE FORCE SHOULD NOT BE USED WHEN THE DEVICE HAS DIFFICULTY CROSSING THE STENOTIC VALVE. ADDING TENSION TO THE WIRE, PULLING BACK THE SYSTEM TO RE-ORIENT THE VALVE, AS NEEDED, AND TORQUEING OF THE FLEX CATHETER MAY BE HELPFUL IN SOLVING THE PROBLEM. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. SPECIFIC CLINICAL AND PROCEDURAL DETAILS ARE NOT AVAILABLE TO DETERMINE POTENTIAL CONTRIBUTING FACTORS TO THE EVENT, OR IF THE EVENT IS RELATED TO AN EDWARDS DEVICE. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE EXEMPTION NUMBER FIELD PER FDA REQUEST ON 07/07/2022.

    Description of Event or Problem · 0

    THV/TVT REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR QUARTER 2 2022 DATA EXTRACT FOR AORTIC DEATH EVENTS FOR THE SAPIEN 3 ULTRA VALVE. THIS REPORT SUMMARIZES 5 AORTIC DISSECTION DEATH EVENTS FOR THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE. THE AGE RANGE FOR THESE EVENTS IS 75-98 YEARS. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 4 FEMALES AND 1 MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609076 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES LLC COMMANDER DELIVERY SYSTEM UNKNOWN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown Death