BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 23MM

    MDR report key: 4202780 · Received October 27, 2014

    Report

    Report Number
    2015691-2014-02520
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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, PER REPORT, THE PATIENT HAD CALCIUM IN THE ANNULUS/LVOT. IN ADDITION, THE INITIAL READ OF THE ECHO AT THE TIME OF IMPLANT WAS CONSERVATIVE AND POSSIBLE THE PVL WAS GREATER THAN ORIGINALLY THOUGHT. 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

    AS REPORTED, MODERATE AORTIC INSUFFICIENCY (AI) WAS NOTED ON ECHO AT THE 30 DAY FOLLOW UP VISIT. A SUCCESSFUL PVL PLUG PROCEDURE WAS PERFORMED. AT THE LAST REPORT, THE PATIENT WAS DOING WELL. INITIALLY, POST DEPLOYMENT ECHO REVEALED TRIVIAL-MILD PVL. PER REPORT, AFTER FURTHER REVIEW THE INITIAL READ AT TIME OF IMPLANT WAS CONSERVATIVE AND POSSIBLY THE AI WAS GREATER THAN TRACE TO MILD. CALCIUM IN ANNULUS /LVOT WAS NOTED AND A PVL JET ALONGSIDE THE CALCIUM MAY NOT HAVE BEEN NOTED AT THE TIME OF IMPLANT. THE NATIVE AORTIC ANNULAR DIAMETER MEASURED 19MM BY TEE AND 17.8MM X 24.85MM WITH AN AREA OF 407MM2 BY CT. AS REPORTED, THE NATIVE VALVE WAS MILDLY CALCIFIED, THE NATIVE LEAFLET WAS MODERATELY CALCIFIED AND NO CALCIFICATION WAS NOTED IN THE AORTIC ROOT. COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, AND THE IMAGE INTENSIFIER ANGLE WAS GOOD. DURING DEPLOYMENT, VENTILATION WAS NOT HELD BUT PACING CAPTURE WAS NOT LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683219 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 23MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention