BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 3964272 · Received July 29, 2014

    Report

    Report Number
    2015691-2014-01719
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 (E.G. BULKY NATIVE VALVE CALCIFICATION), IN ADDITION TO FAIR COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND VALVE AND FAIR IMAGE INTENSIFIER ANGLE 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

    POST 23MM SAPIEN XT VALVE DEPLOYMENT, ECHO INDICATED GOOD PLACEMENT OF A 23MM SAPIEN XT VALVE; FINAL POSITION OF 60:40 AORTIC/VENTRICULAR WITH MILD-MODERATE PARAVALVULAR LEAK (PVL). POST DILATATION, WITH AN ADDITIONAL 1CC FOR A TOTAL OF 18CC, WAS PERFORMED. POST DILATATION ECHO INDICATED NO CHANGE IN THE PVL AND SECOND VALVE WAS PREPARED WITH AN ADDITIONAL 1CC, FOR A TOTAL OF 18CC. THE INTENDED POSITION OF THE SECOND VALVE WAS 1 CELL BELOW THE FIRST VALVE. DURING INFLATION, THE VALVE MOVED AORTIC WITH A FINAL POSITION ½ OF A CELL BELOW THE FIRST VALVE. THE POST DEPLOYMENT ECHO INDICATED MILD TO MODERATE PVL. THE DOCTOR DID NOT FEEL THERE WAS FULL INFLATION,SO POST DILATATION OF THE SECOND VALVE WAS PERFORMED. POST DILATATION ECHO INDICATED NO CHANGE IN THE MILD-MODERATE PVL. NO FURTHER ACTIONS WERE TAKEN AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS TRANSFERRED FROM THE ROOM IN STABLE CONDITION. THE PATIENT¿S NATIVE ANNULUS WAS 21MM BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WITH BULKY NATIVE VALVE CALCIFICATION. THE COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND VALVE WAS FAIR, AND THE IMAGE INTENSIFIER ANGLE WAS FAIR AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442272 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention