BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVAFLEX+ DELIVERY SYSTEM

    MDR report key: 4013050 · Received August 15, 2014

    Report

    Report Number
    2015691-2014-01879
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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, THE VENTRICULAR PERFORATION WAS ATTRIBUTED TO PROCEDURAL FACTORS (PERFORATION WITH THE GUIDEWIRE). THE PATIENT¿S SMALL VENTRICLE WAS LIKELY A CONTRIBUTING FACTOR. 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

    DURING THE TRANSFEMORAL TAVR PROCEDURE, THE PATIENT SUFFERED A VENTRICULAR PERFORATION DUE TO PERFORATION WITH THE GUIDEWIRE. INITIALLY, THE PHYSICIAN HAD A DIFFICULT TIME POSITIONING THE GUIDEWIRE AT THE BEGINNING OF THE PROCEDURE. THE VALVE WAS ABLE TO BE IMPLANTED WITHOUT COMPLICATIONS. UPON REMOVAL OF THE WIRE FROM THE PATIENT'S VENTRICLE, THE PATIENT'S PRESSURE DROPPED. A PERICARDIAL EFFUSION WAS NOTED AND THE PATIENT WAS PREPPED FOR A PERICARDIOCENTESIS. THE PHYSICIAN MADE AN INCISION ON THE CHEST (CHEST WAS NOT CRACKED OPEN) IN ORDER TO ACCESS THE PERICARDIUM. THE PERICARDIAL EFFUSION WAS DRAINED AND THE PATIENT WAS TRANSFERRED OUT OF THE OPERATING ROOM IN STABLE CONDITION. ONE DAY POST PROCEDURE THE PATIENT WAS NOTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489578 NOVAFLEX+ DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9355FS26

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention