BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U

    MDR report key: 11178365 · Received January 15, 2021

    Report

    Report Number
    2015691-2021-00176
    Event Type
    Death
    Date Received
    January 15, 2021
    Date of Event
    December 21, 2020
    Report Date
    December 21, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), 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 SAPIEN 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, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. PER MEDICAL OPINION THE EVENT WAS LIKELY DUE TO PATIENT ANATOMICAL CHARACTERISTICS. 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

    AS REPORTED BY AN EDWARDS LIFESCIENCES AFFILIATE IN (B)(6), POST IMPLANT OF A 26 MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION VIA SUBCLAVIAN APPROACH THE PATIENT DEVELOPED HYPOTENSION AND CARDIAC ARRHYTHMIA. A STERNOTOMY WAS PERFORMED AND REVEALED A LEFT VENTRICULAR WIRE PERFORATION. SURGICAL INTERVENTION WAS PERFORMED, HOWEVER THE PATIENT EXPIRED. PER MEDICAL OPINION, THE EVENT WAS DUE TO PATIENT ANATOMY AND ANATOMICAL CHARACTERISTICS THAT COMPLICATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74315 EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9610TF26U 63228152

    Patients

    Seq Age Sex Outcome Treatment
    1