BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3200151 · Received July 1, 2013

    Report

    Report Number
    2015691-2013-20502
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTIONS FOR USE (IFU), ARRHYTHMIAS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BALLOON VALVULOPLASTY, THE USE OF LOCAL AND/OR GENERAL ANESTHESIA, AORTIC VALVE REPLACEMENT AND THE OVERALL TAVR PROCEDURE. PERI-PROCEDURAL VENTRICULAR ARRHYTHMIAS CAN BE ASSOCIATED WITH PATIENT AND PROCEDURAL FACTORS SUCH AS POOR VENTRICULAR FUNCTION, INADEQUATE CORONARY PERFUSION, HYPOVOLEMIA, ANNULAR RUPTURE/ AORTIC DISSECTION, TAMPONADE, WIRE AND CATHETER MANIPULATION AND BURST PACING. THESE PATIENTS CAN BE NON-OPERATIVE OR HIGH RISK, HAVE COMPLEX MEDICAL HISTORIES AND MULTIPLE CO-MORBIDITIES. THEY ARE ROUTINELY ADMINISTERED MULTIPLE VASOACTIVE DRUGS DURING THE PROCEDURE AND ARE INTENTIONALLY MADE HYPOTENSIVE, UTILIZING RAPID VENTRICULAR PACING, TO FACILITATE ACCURATE VALVE DEPLOYMENT. AS A RESULT OF THESE FACTORS, INTRA-OPERATIVE ARRHYTHMIAS AND HYPOTENSION ARE VERY COMMON AND ARE TREATED WITH STANDARD THERAPIES, INCLUDING ADDITIONAL VASOACTIVE DRUGS OR ELECTRICAL CONVERSION. IT IS ALSO NOT UNCOMMON TO INITIATE BRIEF CHEST COMPRESSIONS OR CARDIAC MASSAGE TO FACILITATE DISTRIBUTION OF THESE VASOACTIVE DRUGS. IF THESE STANDARD MANEUVERS ARE NOT ADEQUATE, INITIATION OF CARDIOPULMONARY BYPASS (CPB), INSERTION OF IABP, AND/OR CONVERSION TO OPEN SURGERY MAY BE REQUIRED. IN THIS CASE THE EXACT CAUSE OF THE EVENT IS NOT CONFIRMED BUT MAY HAVE BEEN CAUSED PATIENT AND PROCEDURAL FACTORS. IT IS POSSIBLE THAT BURST PACING IN A PATIENT WITH A HISTORY OF ARRHYTHMIA AND AN EJECTION FRACTION OF 45% MAY HAVE CONTRIBUTED TO THE CARDIAC ARREST AND VENTRICULAR TACHYCARDIA. 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 THE EDWARDS FIELD CLINICAL SPECIALIST, FOLLOWING THE TRANSFEMORAL DEPLOYMENT OF A 26 MM SAPIEN VALVE UNDER RAPID VENTRICULAR PACING (RVP), THE PHYSICIAN NOTED THAT THE PATIENT'S LEFT VENTRICLE WAS NOT FUNCTIONING APPROPRIATELY. CARDIOPULMONARY RESUSCITATION (CPR) WAS ADMINISTERED, PARTLY TO INCREASE MEDICATION CIRCULATION. CPR LASTED FOR 2 MINUTES AND 15 SECONDS. POST CPR, THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA (VT)WAS DEFIBRILLATED WHICH RESOLVED THE VT, BUT THEN THE VT CAME BACK. THE PATIENT WAS THEN SUCCESSFULLY PACED OUT OF THE SLOW VT WITH HIS INTERNAL PACEMAKER. THE PATIENT WAS THEN TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT HAD A PERMANENT PACEMAKER (PPM) IMPLANTED PRIOR TO THE TAVR. PRIOR TO VALVE DEPLOYMENT, BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED UNDER RAPID PACING WITHOUT ISSUE. THE SAPIEN VALVE WAS POSITIONED AND IMPLANTED IN A 50:50 POSITION ACROSS THE NATIVE AORTIC ANNULUS, RESULTING IN TRACE CENTRAL AND PARAVALVULAR LEAKS. THE PATIENT¿S EJECTION FRACTION WAS 45%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297752 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention