BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 4002384 · Received August 12, 2014

    Report

    Report Number
    2015691-2014-01843
    Event Type
    Injury
    Date Received
    August 12, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, 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. IN THIS CASE, PATIENT FACTORS (SEVERE BULKY NATIVE VALVE CALCIFICATION AND THE ASYMMETRICAL ANNULUS) LIKELY CONTRIBUTED TO THIS EVENT. 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

    DURING THE TRANSAPICAL TAVR PROCEDURE, A 29MM SAPIEN XT VALVE WAS DEPLOYED WITH A FINAL 50:50 AORTIC/VENTRICULAR POSITION, RESULTING IN MODERATE PARAVALVULAR LEAK (PVL). AN ADDITIONAL 2CC¿S WERE ADDED TO THE DELIVERY SYSTEM BALLOON. POST DILATION WAS PERFORMED WITH NO IMPROVEMENT IN THE PVL. A SECOND VALVE WAS PREPPED AND DEPLOYED, RESULTING IN MILD PVL. THE PATIENT¿S NATIVE ANNULUS MEASURED 24.5MMX32MM BY CT (VALVE AREA OF 606MM2), WITH SEVERE NATIVE VALVE CALCIFICATION AND MODERATE AORTIC ROOT CALCIFICATION NOTED. A LARGE NODULE OF CALCIUM IN THE LCC EXTENDING INTO THE LVOT WAS ALSO NOTED. THIS WAS DETERMINED TO HAVE PREVENTED THE COMPLETE SEAL OF THE VALVE IN THAT LOCATION, RESULTING IN PVL POST VALVE DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480055 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX29

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention