BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3942309 · Received July 17, 2014

    Report

    Report Number
    2015691-2014-01613
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 24, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, DEVICE MALPOSITION AND PARAVALVULAR LEAK (PVL) IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE PATIENT SCREENING MANUAL AND THE PROCEDURE DIDACTIC IDENTIFY SEVERAL PROCEDURAL AND ANATOMICAL FACTORS WHICH COULD CONTRIBUTE TO PVL, INCLUDING DEVICE MALPOSITION, INACCURATE MEASUREMENT OF THE NATIVE VALVE ANNULUS, UNEVEN DISTRIBUTION OF CALCIUM ON THE NATIVE VALVE, BULKY OR SEVERE CALCIFICATION, AN ELLIPTICAL ANNULUS SHAPE AND VALVE UNDER-SIZING. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER AORTIC VALVE & ROOT ASSESSMENT, INCLUDING THE USE OF ECHO, AORTOGRAM AND CT TO APPROPRIATELY MEASURE THE ANNULUS DIAMETER, CONTENT AND DISTRIBUTION OF CALCIUM, AND LEAFLET CHARACTERISTICS. CONTRAINDICATIONS, IMPORTANT CONSIDERATIONS WHEN ASSESSING THE VALVE, AND CHOOSING THE PROPER THV ARE ALSO DISCUSSED. THE THV TRAINING MANUALS ALSO INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES ARE ALSO INCLUDED. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO AORTIC MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMALLY OR SEVERELY CALCIFIED AORTIC LEAFLETS, PRESERVED EJECTION FRACTION, SIGNIFICANT MITRAL ANNULAR CALCIFICATION (MAC), LOSS OF PACING CAPTURE, AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. DEPLOYMENT OF THE SAPIEN VALVE TOO AORTIC HAS THE POTENTIAL TO CONTRIBUTE TO SUBOPTIMAL COAPTATION OF THE SAPIEN VALVE LEAFLETS AND CAUSE CENTRAL AORTIC INSUFFICIENCY; IT CAN OBSTRUCT THE CORONARY OSTIA; AND LEAD TO EMBOLIZATION OF THE PROSTHESIS INTO THE ASCENDING AORTA. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICE AT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR TO THE PLACEMENT AND FIXATION OF THE DEVICE. OPERATORS ARE ALSO INSTRUCTED TO USE FLUOROSCOPY AS THE PRIMARY METHOD OF VISUALIZATION FOR POSITIONING AND DEPLOYMENT. IN PATIENTS WITH HIGH-RISK ANATOMICAL FEATURES FOR AORTIC MALPOSITION (I.E. MINIMAL LEAFLET CALCIFICATION, SEVERE SEPTAL HYPERTROPHY), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT IN THIS CASE, THE EXACT CAUSE OF THE TOO AORTIC PLACEMENT IS UNKNOWN. MULTIPLE UNKNOWN FACTORS INCLUDING NATIVE LEAFLET/VALVE CALCIFICATION, IMAGE INTENSIFIER ANGLE, AND COAXIAL ALIGNMENT MAY HAVE CONTRIBUTED TO THE MALPOSITION AND SUBSEQUENT PVL. 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 SAPIEN VALVE DEPLOYMENT, THE VALVE LANDED TOO AORTIC, WITH SIGNIFICANT PARAVALVULAR LEAK (PVL). A SECOND VALVE WAS PLACED. THE 26 MM SAPIEN VALVE WAS PREPARED, ITS CORRECT ORIENTATION CONFIRMED AND DELIVERED VIA THE SHEATH, CROSSING INTO POSITION EASILY. A SINGLE AORTIC INJECTION WAS PERFORMED TO POSITION THE VALVE. WHEN SATISFACTORY POSITION WAS OBTAINED THE VALVE WAS DEPLOYED UNDER RAPID VENTRICULAR PACING AND WITH A SECOND SIMULTANEOUS AORTIC INJECTION TO ADJUST POSITION. THE DEPLOYMENT, WHILE SECURE WAS ¿SOMEWHAT HIGH.¿ THE PATIENTS' BLOOD PRESSURE RECOVERED AND A TTE SHOWED BOTH CENTRAL AORTIC INSUFFICIENCY (CAI) (WIRE-RELATED) AND PVL. THE VALVE WAS REDILATED WITH AN ADDITIONAL 1ML OF FLUID. THE PARAVALVULAR REGURGITATION WAS REDUCED BUT NOT SUFFICIENTLY SO A SECOND VALVE WAS PREPARED. THE SECOND VALVE WAS DEPLOYED 2-3 MM LOWER THAN THE FIRST. THE CENTRAL REGURGITATION WAS RESOLVED WITH REMOVAL OF THE DELIVERY WIRE AND THERE WAS NO LONGER ANY SIGNIFICANT PVL. THE PATIENT WAS TRANSFERRED TO CCU ALERT AND COMFORTABLE. THIS PATIENT HAD ¿SEVERE AORTIC STENOSIS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419390 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention