BEUDAMED
    FDA Adverse Event Death Summary report: N

    TF NF3 DEL SYS, 29MM, COM

    MDR report key: 5076310 · Received September 14, 2015

    Report

    Report Number
    2015691-2015-02401
    Event Type
    Death
    Date Received
    September 14, 2015
    Date of Event
    July 10, 2014
    Report Date
    August 17, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 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, A VENTRICULAR PERFORATION BY THE GUIDEWIRE AND RESULTING PERICARDIAL EFFUSION WAS OBSERVED ON IMAGING AFTER VALVE DEPLOYMENT. THE EVENT APPEARS TO BE RELATED TO DEVICE MANIPULATION. 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.

    Additional Manufacturer Narrative · 1

    MEDWATCH REPORT #2015691-2015-02407 PERTAINS TO THIS SAME EVENT AND PATIENT (MEDWATCH REPORT #2015691-2015-02401).

    Description of Event or Problem · 1

    AS FOUND UPON REVIEW OF MEDICAL RECORDS, DURING A TRANSFEMORAL TAVR PROCEDURE, SEVERAL ATTEMPTS WERE MADE TO ALIGN THE VALVE IN THE ANNULUS AND THE WIRE WAS MOVED BACK AND FORTH UNTIL THE VALVE APPEARED TO BE IN A GOOD POSITION. AFTER VALVE DEPLOYMENT THE PATIENT'S EKG SHOWED ISCHEMIA, THE PRESSURE DROPPED AND THEN NO CARDIAC OUTPUT WAS OBTAINED. THE PATIENT WAS GIVEN EPINEPHRINE, COMPRESSIONS WERE STARTED, THE DELIVERY SYSTEM WAS REMOVED AND THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS. POST OPERATIVE IMAGING REVIEW DEMONSTRATED THE WIRE WAS OUTSIDE THE VENTRICLE POST VALVE DEPLOYMENT. ON TEE THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. A STERNOTOMY WAS PERFORMED AND A TEAR OF THE VENTRICLE WAS DETECTED. THE VENTRICLE WAS ATTEMPTED TO BE SURGICALLY REPAIRED, AN INTRA AORTIC BALLOON PUMP WAS PLACED AND MULTIPLE UNITS OF BLOOD WERE GIVEN. HOWEVER, THE PATIENT HAD LOW BLOOD PRESSURE AND ONGOING BLEEDING AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604984 TF NF3 DEL SYS, 29MM, COM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9355FS29

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death