BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 4093632 · Received September 16, 2014

    Report

    Report Number
    2015691-2014-02159
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 ANNULAR CALCIFICATION AND SEVERE NATIVE LEAFLET CALCIFICATION) LIKELY CONTRIBUTED TO THE CANTED POSITION AND 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 THE TRANSAORTIC TAVR PROCEDURE, A 26MM SAPIEN VALVE WAS DEPLOYED WITH A FINAL 50:50 AORTIC/VENTRICULAR POSITION. DUE TO ONE HEAVILY CALCIFIED LEAFLET ON THE NON-CORONARY CUSP, THE VALVE WAS SLIGHTLY TILTED/CANTED, 1 TO 2 DEGREES, RESULTING IN MODERATE PARAVALVULAR LEAK (PVL). THE PVL WAS OVER THE SKIRTED AREA IN THE SECTION OF THE CALCIFIED NATIVE LEAFLET. A SECOND VALVE WAS POSITIONED APPROXIMATELY 1 CELL HIGHER THAN THE FIRST VALVE, AND DEPLOYED WITH A FINAL 60:40 A/V POSITION; CORRECTING THE PVL. AT THE TIME OF THIS REPORT, THE PATIENT WAS DOING GREAT, WITH LESS POST PRESSURE AND IMPROVED DIASTOLIC BLOOD PRESSURE. THE PATIENT¿S NATIVE ANNULUS MEASURED 24MM (VALVE AREA OF 4.66CM2 BY CT) WITH SEVERE ANNULAR CALCIFICATION, SEVERE NATIVE LEAFLET CALCIFICATION AND NO AORTIC ROOT CALCIFICATION NOTED. SLIGHT CALCIFICATION OF THE LVOT AND MODERATE CALCIFICATION OF THE SINOTUBULAR JUNCTION (STJ) WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573426 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention