BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOVAFLEX + DELIVERY SYSTEM, 26

    MDR report key: 3983595 · Received August 6, 2014

    Report

    Report Number
    2015691-2014-01793
    Event Type
    Death
    Date Received
    August 6, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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, AS PER REPORT, THE VENTRICLE PUNCTURE WAS ATTRIBUTED TO THE PATIENT¿S SMALL LEFT VENTRICULAR CAVITY. 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

    THIS PATIENT DIED AFTER VENTRICULAR PERFORATION DURING A TRANSFEMORAL TAVR PROCEDURE. AS REPORTED, A 26MM SAPIEN XT VALVE WAS DEPLOYED IN AORTIC ANNULUS WITHOUT INCIDENT. UPON REMOVAL OF THE AMPLATZ EXTRA-STIFF WIRE FROM THE LEFT VENTRICLE A RAPID DECREASE IN SYSTOLIC BLOOD PRESSURE WAS NOTED. A TEE DEMONSTRATED A POSTERIOR PERICARDIAL EFFUSION, WHICH WAS DRAINED VIA PERICARDIOCENTESIS. MAINTAINING THE SYSTOLIC BLOOD PRESSURE REMAINED CHALLENGING DESPITE THE USE OF VASOPRESSORS; THE PATIENT WAS PLACED ON BYPASS, AND MULTIPLE BLOOD TRANSFUSIONS WERE GIVEN. A LEFT SIDED MINI-THORACOTOMY WAS PERFORMED AND A LEFT VENTRICULAR PERFORATION WAS NOTED. THE PERFORATION WAS CLOSED IN NORMAL SURGICAL FASHION. AFTER MULTIPLE ATTEMPTS TO CONTROL THE BLEEDING INTO THE PERICARDIAL SPACE THE PATIENT EXPIRED. PER REPORT, THE AMPLATZ EXTRA-STIFF WIRE PERFORATION OF THE LEFT VENTRICLE WAS ATTRIBUTED TO THE PATIENT¿S SMALL LEFT VENTRICULAR CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461956 NOVAFLEX + DELIVERY SYSTEM, 26 AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9355FS26 59603094

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death