BEUDAMED
    FDA Adverse Event Death Summary report: Y

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 10857908 · Received November 17, 2020

    Report

    Report Number
    2015691-2020-14467
    Event Type
    Death
    Date Received
    November 17, 2020
    Date of Event
    October 26, 2020
    Report Date
    October 26, 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> 20  </NOE> DEATH EVENTS OF PERFORATION WITH OR WITHOUT TAMPONADE FOR THE SAPIEN 3 FOR (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016006, THIS REPORT SUMMARIZES 20 EVENTS OF PERFORATION WITH OR WITHOUT TAMPONADE FOR THE SAPIEN 3 IN THE AORTIC POSITION. THE ¿TIME TO EVENT¿ (TTE, IN DAYS) FOR THIS EVENT WAS 0.15. 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 THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE SEVERAL POTENTIAL ETIOLOGIES FOR VENTRICULAR PERFORATION DURING A TAVR 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 THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PROPER GUIDEWIRE POSITIONING, FIXATION OF THE TVP TO PREVENT VENTRICLE PERFORATION, AND CAREFUL MANIPULATION OF DEVICES. PER THE PROCEDURE DIDACTIC, PATIENTS WITH SMALL VENTRICLES ARE AT PARTICULARLY HIGH RISK FOR VENTRICULAR PERFORATION. 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 ALTERNATIVE SUMMARY REPORTING (ASR) ADVERSE EVENT SUBMISSION FOR AUGUST 2020 DATA EXTRACT FOR AORTIC DEATHS FOR THE SAPIEN 3. AUGUST 2020 DATA EXTRACT INCLUDES DATA PROVIDED BY ACC FOR Q1 2020 (JANUARY 1 ¿ MARCH 31, 2020). THIS REPORT SUMMARIZES 20 DEATH EVENTS OF PERFORATION WITH OR WITHOUT TAMPONADE FOR THE SAPIEN 3 FOR AUGUST 2020. THE AGE RANGE FOR THESE EVENTS ARE FROM 69 TO 92. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 11 MALE AND 9 FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314962 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES COMMANDER DELIVERY SYSTEM UNKNOWN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death