BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS TRANSFEMORAL BALLOON CATHETER

    MDR report key: 3944539 · Received July 18, 2014

    Report

    Report Number
    2015691-2014-01630
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    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 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 VENTRICLE PERFORATION COULD NOT BE DETERMINED. IT IS LIKELY THAT THE PERFORATION BEGAN WITH THE BAV AND WIRE MOVEMENT BUT WAS NOT APPRECIATED ON TEE. 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

    IT WAS REPORTED BY OUR (B)(6) AFFILIATE THAT DURING A TRANSFEMORAL TAVR PROCEDURE THE PATIENT¿S LEFT VENTRICLE (LV) WAS PERFORATED. REPORTEDLY WHILE THE BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED, THE 23X4 BALLOON SLIPPED INTO THE LEFT VENTRICULAR (LV) AND THE GUIDEWIRE MOVED DOWNWARD. WHEN RAPID VENTRICULAR PACING (RVP) WAS TURNED OFF, THE PATIENT¿S BLOOD PRESSURE WENT UP TO 98/42MMHG, SO BAV WAS PERFORMED AGAIN. NO EFFUSION WAS OBSERVED BY TEE WHEN ASSESSED FROM FRONT SIDE OF THE RIGHT VENTRICLE; HOWEVER THERE WAS NO INFORMATION FROM THE BACK SIDE OF LV. AT THIS POINT THE PATIENT WAS HEMODYNAMICALLY STABLE. A DELIVERY SYSTEM WAS INSERTED AND CROSSED THE PATIENT¿S NATIVE ANNULUS. THE BLOOD PRESSURE WAS 107/43MMHG. THE BLOOD PRESSURE STARTED TO DROP WHEN ANGIOGRAPHY FOR A 23MM SAPIEN XT VALVE POSITIONING WAS PERFORMED. THE OPERATOR TRIED TO RAISE THE SYSTOLIC BLOOD PRESSURE (SBP) BUT IT WAS IN THE 40¿S MMHG. SINCE THE XT VALVE REMAINED IN THE NATIVE VALVE, THE OPERATOR THOUGHT THE FLOW WAS LOW. THE SAPIEN XT VALVE WAS DEPLOYED UNDER RVP. FOLLOWING VALVE DEPLOYMENT RVP WAS TURNED OFF BUT THE PATIENT¿S BLOOD PRESSURE DID NOT IMPROVE FROM 24/12MMHG AND CHEST COMPRESSIONS WERE STARTED. WHILE PREPPING PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) AN EFFUSION WAS OBSERVED AND IT RAPIDLY CHANGED TO PERICARDIAL TAMPONADE. THE PCPS WAS NOT USED AND PERICARDIAL DRAINAGE WAS PERFORMED. DURING CHEST COMPRESSION, THE BLOOD PRESSURE WAS 77/18MMHG; BUT NOTABLY DROPPED WHEN CHEST COMPRESSION WERE STOPPED. PERICARDIAL FLUID WAS DRAINED GRADUALLY TARGETING THE SBP IN THE 80¿S MMHG. CHEST COMPRESSIONS WERE STOPPED AND THE BLOOD PRESSURE REMAINED AT 74/56MMHG AND HEART RATE WAS 129BPM. A LEFT VENTRICULOGRAM SHOWED CONTRAST LEAK FROM THE APEX. PROTAMINE WAS GRADUALLY REVERSED AND DRAINAGE WAS CONTINUED. NORADRENALINE WAS ADMINISTERED AND BLOOD INFUSION WAS ADDED AS REQUIRED. THE BLOOD PRESSURE WAS RETAINED, HOWEVER IT BECAME DIFFICULT TO RAISE BLOOD PRESSURE WITH NORADRENALINE, AND PCPS WAS PREPARED AGAIN. PROTAMINE WAS FULLY REVERSED BUT THE PATIENT¿S BLOOD PRESSURE WAS UNSTABLE. ECHO SHOWED A FLOW FROM THE AREA THAT WAS THOUGHT TO BE THE HEMORRHAGIC SPOT. IT WAS DECIDED TO PERFORM A THORACOTOMY, AFTER OBTAINING PATIENT¿S FAMILY CONSENT. MEDIAN STERNOTOMY WAS PERFORMED AND BLEEDING WAS STOPPED. A TEAR OF ABOUT 7 OR 8CM WAS OBSERVED ON THE APEX. THE PATIENT WAS EXTUBATED AND LEFT THE OPERATION ROOM; THE HEMOSTASIS CONDITION WAS GOOD. THE OPERATOR COMMENTED, UPON REVIEWING CINE, THAT THE GUIDEWIRE WAS TOO ADVANCED TWICE; FIRST TIME WAS WHEN THE BAV SLIPPED INTO THE LV AND THE SECOND TIME WAS WHEN THE DELIVERY SYSTEM CROSSED THE NATIVE VALVE. THE TIMING OF THE PERFORATION WAS NOT DETERMINED. AN AMPLATZ EXTRA STIFF GUIDE WIRE WAS USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423304 EDWARDS TRANSFEMORAL BALLOON CATHETER INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9350BC20J 59709872

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention