BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 4102847 · Received September 19, 2014

    Report

    Report Number
    2015691-2014-02183
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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, THE CAUSE OF THE WORSENING PVL 18 DAYS POST TAVR CANNOT BE CONFIRMED. IT IS POSSIBLE THAT, IN ADDITION TO POSSIBLE UNDERSIZING OF THE VALVE, PATIENT FACTORS (SEVERE LEAFLET AND EXTENSIVE LVOT CALCIFICATION) MAY HAVE 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 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

    EIGHTEEN (18) DAYS POST TAVR PROCEDURE, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) INDICATED A PARAVALVULAR LEAK (PVL) WORSENING FROM MILD TO MODERATE AT DISCHARGE TO MODERATE-SEVERE. INTERVENTION WAS REQUIRED. AS REPORTED, DURING THE TRANSFEMORAL TAVR PROCEDURE, A 26MM SAPIEN XT VALVE WAS DEPLOYED WHERE PLANNED, WITH A FINAL 60:40 AORTIC/VENTRICULAR POSITION, RESULTING IN MODERATE PVL. TWO POST-DILATIONS OF THE VALVE WERE PERFORMED, RESULTING IN MILD-MODERATE PVL. EIGHTEEN (18) DAYS POST TAVR, THE PATIENT WAS RE-ADMITTED FOR SHORTNESS OF BREATH (SOB) AND HEART FAILURE. TEE INDICATED MODERATE-SEVERE PVL. TWENTY-ONE (21) DAYS POST TAVR, ONE OF THE THREE PVL JETS WAS CLOSED WITH AN 8MM AMPLATZER VASCULAR PLUG. AN ATTEMPT WAS MADE TO CLOSE ONE OTHER PVL JET, BUT THE CATHETERS WERE UNABLE TO CROSS INTO THE LEFT VENTRICLE (LV). AT THE END OF THE PROCEDURE THE PVL WAS REDUCED TO MILD-MODERATE. THE PATIENT WAS TRANSFERRED TO ICU IN STABLE CONDITION. THE PATIENT¿S NATIVE ANNULUS AREA MEASURED 480MM2 BY 3D TEE BY THE SITE ON CASE DAY, 528MM BY CT, AND 530-560MM2 BY THE EDWARDS FIELD CLINICAL SPECIALIST (FCS). MODERATE ANNULAR CALCIFICATION, SEVERE LEAFLET CALCIFICATION, MILD AORTIC ROOT CALCIFICATION, AND EXTENSIVE LVOT CALCIFICATION WERE REPORTED. CT WAS REPORTED TO BE OF POOR QUALITY ON THE DAY OF THE TAVR PROCEDURE, WITH MOTION ARTIFACT THROUGHOUT THE ANNULUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585187 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention