BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3172994 · Received June 17, 2013

    Report

    Report Number
    2015691-2013-20366
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), DEVICE MALPOSITION REQUIRING INTERVENTION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VENTRICULAR MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, A NARROW, CALCIFIED SINOTUBULAR JUNCTION, MINIMALLY CALCIFIED AORTIC LEAFLETS, AND LOSS OF PACING CAPTURE. PARAVALVULAR LEAK CAN OCCUR AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE WHICH CAN OCCUR DUE TO UNEVEN DISTRIBUTION OF CALCIUM. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. 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 VENTRICULAR MALPOSITION (I.E. SMALL, CALCIFIED STJ, MINIMAL LEAFLET CALCIFICATION), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. IN THIS CASE, PATIENT AND PROCEDURAL FACTORS APPEAR TO HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. THE INFORMATION AVAILABLE INDICATES THIS PATIENT¿S SINOTUBULAR JUNCTION WAS NARROW AND CALCIFIED, AND THE AORTIC VALVE AND AORTIC ROOT WERE SEVERELY CALCIFIED. DURING THE CASE THERE WAS DIFFICULTY ALIGNING THE SHEATH WHICH PROBABLY CONTRIBUTED TO LESS THAN OPTIMA COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND THE VALVE PRIOR TO DEPLOYMENT. 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

    A REPORT WAS RECEIVED THROUGH THE EDWARDS IMPLANT PATIENT REGISTRY (IPR) INDICATING TWO 26MM SAPIEN VALVES WERE IMPLANTED DURING A TAVR CASE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE EDWARDS CLINICAL SPECIALIST PRESENT AT THE CASE. PER HIS REPORT, THIS WAS A TRANSAPICAL TAVR CASE, THE FIRST VALVE WAS DEPLOYED IN A TOO VENTRICULAR POSITION (30:70) AND PARAVALVULAR LEAK (PVL) WAS PRESENT. THUS A SECOND VALVE WAS IMPLANTED MORE AORTIC RESOLVING THE PVL. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND WAS REPORTED AS DOING WELL AFTER THE PROCEDURE. THE CLINICAL SPECIALIST INDICATED THERE WAS DIFFICULTY ALIGNING THE SHEATH DURING ENTRY INTO THE VENTRICLE AND THAT DURING DEPLOYMENT, FOR UNKNOWN REASONS, THE VALVE ENDED UP MORE VENTRICULAR. THE PATIENT¿S SINOTUBULAR JUNCTION WAS DESCRIBED AS NARROW AND CALCIFIED. THERE WAS NO SEVERE VENTRICULAR SEPTAL HYPERTROPHY. THE AORTIC VALVE, LEAFLET, AND AORTIC ROOT CALCIFICATION WERE DESCRIBED AS SEVERE. THE PATIENT¿S EJECTION FRACTION WAS 60 PERCENT. IMAGE INTENSIFIER ANGLE WAS DESCRIBED AS GOOD. THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WAS FAIR. THE SAPIEN VALVE POSITION AT PRE-DEPLOYMENT WAS 50:50. THE BALLOON INFLATION WAS HELD DURING DEPLOYMENT FOR FIVE SECONDS AND VENTILATION WAS HELD. THERE WAS NO LOSS OF PACING CAPTURE DURING DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273023 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26 3207151

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention