BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVAFLEX+ DELIVERY SYSTEM

    MDR report key: 3973495 · Received August 1, 2014

    Report

    Report Number
    2015691-2014-01760
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    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, DURING PROCEDURAL IMAGE REVIEW IT WAS NOTED THAT THE GUIDEWIRE PERFORATED THE LEFT VENTRICLE. IN ADDITION, THE PATIENT¿S LV TISSUE WAS INDICATED TO BE ¿SOFT¿ AND MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. 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

    POST SAPIEN XT DEPLOYMENT, A LINEAR PERFORATION OF THE LEFT VENTRICLE (LV) WAS DISCOVERED ON THE POSTERIOR ASPECT OF THE LV. DURING THE FINAL VALVE POSITIONING ACROSS THE NATIVE AORTIC ANNULUS, THE PATIENT'S SYSTOLIC BLOOD PRESSURE (SBP) STARTED TO DROP TO AROUND 80MMHG. IT WAS DECIDED THE VALVE POSITION WAS ACCEPTABLE TO DEPLOY THE VALVE IMMEDIATELY. THE VALVE DEPLOYMENT OCCURRED UNEVENTFULLY, AND IN GOOD POSITION, 50:50 ACROSS THE NATIVE ANNULUS. THE NOVAFLEX+ DELIVERY SYSTEM WAS RETRACTED COMPLETELY OUT OF THE VALVE. THE PATIENT'S SBP CONTINUED TO DROP TO AROUND 40MMHG, SO IT WAS DECIDED THAT CPR WAS NEEDED. CPR WAS ADMINISTERED FOR ABOUT 10 MINUTES WITH NO IMPROVEMENT IN HEMODYNAMICS. IT WAS THEN DECIDED TO PLACE THE PATIENT ON CARDIOPULMONARY BYPASS. A PERICARDIAL EFFUSION WAS SEEN VIA TEE, ABOUT 4CM, WHICH WAS NOT SEEN AT BASELINE OF PROCEDURE. AFTER THE PATIENT WAS ON BYPASS AND STABILIZED, IT WAS DECIDED TO CONVERT TO AN OPEN SURGICAL PROCEDURE TO FIND ROOT CAUSE OF THE PERICARDIAL EFFUSION. A LINEAR PERFORATION OF THE LV WAS DISCOVERED ON THE POSTERIOR ASPECT OF THE LV. APPROXIMATELY 20 SURGICAL PLEDGETS WERE PLACED TO REPAIR THE LV TEAR. THE LV TISSUE IN AREA OF THE PERFORATION WAS NOTED BY THE OPERATING SURGEON TO BE 'SOFT'. DURING A REVIEW OF THE FLUORO IMAGES THE CURVED PORTION OF THE AMPLATZ XS GUIDEWIRE WAS SEEN TO BE OUTSIDE OF THE LV DURING THE DELIVERY OF THE SAPIEN XT VALVE. THE CURVED PORTION OF WIRE PERFORATED THE POSTERIOR ASPECT OF THE LV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450673 NOVAFLEX+ DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9355FS29 59660498

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention