BEUDAMED
    FDA Adverse Event Death Summary report: Y

    EDWARDS ULTRA DELIVERY SYSTEM

    MDR report key: 10332923 · Received July 28, 2020

    Report

    Report Number
    2015691-2020-12733
    Event Type
    Death
    Date Received
    July 28, 2020
    Date of Event
    May 29, 2020
    Report Date
    July 23, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    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 · 0

    SUPPLEMENTAL REPORT TO ADD NOE STATEMENT IN B5 SECTION, AND PROVIDE D5, AND H6 INFORMATION.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZE <NOE> 2 </NOE> EVENTS OF AORTIC DISSECTION DEATH EVENTS FOR THE ULTRA DELIVERY SYSTEM FOR (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016006, THIS REPORT SUMMARIZES 2 EVENTS OF AORTIC DISSECTION WITH THE ULTRA DELIVERY SYSTEM IN THE AORTIC POSITION. THE ¿TIME TO EVENT¿ (TTE, IN DAYS) FOR THIS EVENT WAS 0. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS ULTRA DELIVERY SYSTEM ARE: (B)(4). 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 TORQUING OF THE FLEX CATHETER MAY BE HELPFUL IN SOLVING THE PROBLEM. 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 (B)(6) 2020 DATA EXTRACT FOR AORTIC DEATH FOR THE SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION. THIS REPORT SUMMARIZES 2 EVENTS OF AORTIC DISSECTION DEATH EVENTS FOR THE ULTRA DELIVERY SYSTEM FOR (B)(6) 2020. THE AGE RANGE FOR THESE EVENTS IS FROM 85-88. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 2 FEMALES. MAY 2020 DATA EXTRACT INCLUDES DATA PROVIDED BY ACC FOR Q4 2019 (OCTOBER 1 ¿ DECEMBER 31).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797151 EDWARDS ULTRA DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES ULTRA DELIVERY SYSTEM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death