BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVAFLEX+ DELIVERY SYSTEM

    MDR report key: 4704199 · Received April 17, 2015

    Report

    Report Number
    2015691-2015-00867
    Event Type
    Injury
    Date Received
    April 17, 2015
    Date of Event
    March 24, 2015
    Report Date
    March 24, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 XT 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 EXACT CAUSE OF THE VENTRICULAR PERFORATION CANNOT BE DETERMINED. HOWEVER, IT MAY HAVE BEEN CAUSED BY THE GUIDEWIRE OR THE NF+ NOSE CONE DURING THE MANEUVERS PERFORMED TO RE-ADJUST THE GUIDEWIRE POSITION IN THE LV. 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY OUR (B)(6) AFFILIATE, UPON REMOVAL OF THE NOVAFLEX+ DELIVERY SYSTEM (NF+), A PERFORATION IN THE LEFT VENTRICLE LATERAL WALL WAS OBSERVED. THE AREA WAS REPAIRED WITH FIBRIN GLUE AND A PERICARDIAL PATCH WAS PLACED. DURING A TRANSFEMORAL TAVR PROCEDURE, WHILE INSERTING THE NF+, A WIRE THAT WAS PLACED IN THE LEFT VENTRICLE (LV) WAS PULLED OUT TO IMMEDIATELY BELOW THE AORTIC VALVE. ALTHOUGH THE WIRE POSITION WAS ATTEMPTED TO BE PLACED BACK INTO THE LV APEX, IT WAS DIFFICULT. THE NF+ WAS CAREFULLY ADVANCED TO THE AORTIC VALVE AND THE WIRE POSITION WAS ADJUSTED, BUT IT MOVED TO THE LATERAL SIDE DUE TO THE PATIENT¿S SIGMOID SEPTUM. FURTHER POSITIONAL ADJUSTMENT OF THE WIRE WAS JUDGED TO BE DIFFICULT AND A 23MM SAPIEN XT WAS IMPLANTED AFTER CHECKING THE WIRE WAS NOT ENTANGLED IN THE CHORDAE TENDINEAE. POST NF+ REMOVAL, THE BLOOD PRESSURE (BP) GRADUALLY DROPPED AND ECHO SHOWED A PERICARDIAL EFFUSION. DRAINAGE WAS PERFORMED AND PROTAMIN WAS GIVEN. ABOUT 30ML OF ARTERIAL-BLOOD-LIKE BLOOD WAS DRAINED. THE BP RECOVERED TO THE 90¿SMMHG BUT IT GRADUALLY DROPPED AGAIN. A MEDIAN STERNOTOMY WAS PERFORMED OFF PUMP AND THE BLEEDING WAS CONFIRMED TO BE COMING FROM THE LV LATERAL WALL. PERFORATION BY A PACING LEAD WAS SUSPECTED BUT IT SEEMED NO PROBLEM AS LONG AS CHECKED IN THE OPERATIVE FIELD. FIBRIN GLUE WAS APPLIED TO THE PERFORATION SITE AND HEMOSTASIS WAS OBTAINED. IN ORDER TO PREVENT RE-BLEEDING AND ANEURYSM DEVELOPMENT, THE PERFORATION SITE WAS PROTECTED WITH A PERICARDIAL PATCH AND THE CHEST WAS CLOSED. PER ECHO VIEW, THE NOSE CONE TOUCHED THE LEFT VENTRICLE LATERAL WALL, SO IT IS UNKNOWN IF THE PERFORATION WAS CAUSED BY THE GUIDEWIRE OR BY THE DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258546 NOVAFLEX+ DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9355FS23J 59749041

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention