BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOVAFLEX+ DELIVERY SYSTEM

    MDR report key: 6197271 · Received December 21, 2016

    Report

    Report Number
    2015691-2016-03853
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    December 7, 2016
    Report Date
    December 9, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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, THE VENTRICULAR PERFORATION WAS CAUSED BY THE GUIDEWIRE WHILE THE DELIVERY SYSTEM WAS ON THE WIRE. 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 THE (B)(6) EDWARDS AFFILIATE, DURING THE IMPLANTATION OF A 29MM SAPIEN XT VALVE BY TF APPROACH, THE VENTRICULAR WALL WAS PUNCTURED WITH THE SUPER STIFF AMPLATZ GUIDEWIRE. THIS LEAD TO A TAMPONADE AND DROPPING BLOOD PRESSURE. TO SOLVE THIS, A THORACOTOMY WAS PERFORMED AND MANAGED TO CLOSE THE PUNCTURE SITE. THE BLOOD PRESSURE RETURNED AND THE VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT LEFT THE CATH LAB HEMODYNAMICALLY STABLE BUT PASSED AWAY 6 HOURS LATER IN ICU. AS PER MEDICAL OPINION, THE PUNCTURE OCCURRED WHEN THE EDWARDS DEVICE WAS ALREADY ON THE WIRE AND THE NOSE CONE WAS IN THE VENTRICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843550 NOVAFLEX+ DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9355FS29 60341310

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| R