BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT? TRANSCATHETER HEART VALVE

    MDR report key: 4251002 · Received November 14, 2014

    Report

    Report Number
    2015691-2014-02698
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    September 17, 2014
    Report Date
    October 22, 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 (IFU), VALVULAR THROMBOSIS AND EMBOLIZATION OF AIR, CALCIFICATION OR THROMBUS ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH TRANSCATHETER AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. VALVE THROMBOSIS IS THE FORMATION OF SIGNIFICANT BLOOD CLOTS FORMING ON THE VALVE. THESE CLOTS COULD SIGNIFICANTLY IMPACT THE FUNCTIONALITY OF THE VALVE RESULTING IN HEART FAILURE OR THROMBOEMBOLISM. ACCORDING TO THE MAYO CLINIC, SOME CAUSES FOR THROMBOEMBOLISM INCLUDE ADVANCED AGE, ATHEROSCLEROSIS, CANCER, PREVIOUS MI, HEART FAILURE, DM, HTN, A SEDENTARY LIFESTYLE, CERTAIN MEDICATIONS, AND SMOKING. DURING THE MANUFACTURING PROCESS, ALL EDWARDS VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR COAPTATION PRIOR TO RELEASE FOR DISTRIBUTION. THIS MAKES IT HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION WOULD CONTRIBUTE TO THE EVENT. IN THIS CASE, THE EXACT CAUSE OF THE VALVE THROMBOSIS IS UNKNOWN. HOWEVER, THE PATIENT¿S MULTIPLE CO MORBIDITIES (HTN, CAD, MI) COULD HAVE CONTRIBUTED TO THE 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; THEREFORE NO FURTHER ACTIONS ARE REQUIRED. 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.

    Description of Event or Problem · 1

    EIGHT DAYS POST SAPIEN XT TRANSAORTIC VALVE PLACEMENT, THROMBOSIS WAS NOTED ON THE PROSTHETIC CARDIAC VALVE. POST VALVE DEPLOYMENT, TEE CONFIRMED GOOD POSITIONING WITH MILD POSTERIOR PARAVALVULAR LEAK (PVL) AND SIGNIFICANT IMPROVEMENT OF HEMODYNAMIC GRADIENTS. THE PATIENT TOLERATED THE PROCEDURE WELL. POST-OP, THE PATIENT DEVELOPED ACUTE RENAL FAILURE REQUIRING HEMODIALYSIS. ON POD 7, THE PATIENT BECAME HYPOTENSIVE. ON POD 8, CODE BLUE WAS CALLED AND THE PATIENT WAS SUCCESSFULLY RESUSCITATED. AT THAT TIME, TEE SHOWED A SMALL PERICARDIAL EFFUSION WITHOUT TAMPONADE, AND UNCHANGED MILD PVL UNCHANGED. ALSO ON THE TEE, A ¿SMALL FILAMENTOUS DENSITY ON THE AORTIC SIDE OF THE VALVE STENT, MOST LIKELY CONSISTENT WITH CLOT¿ WAS SEEN. THE PATIENT WAS MADE DNR AND PLACED ON COMFORT CARE. THE PATIENT EXPIRED WITH HIS FAMILY AT SIDE ON POD 14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738426 EDWARDS SAPIEN XT? TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX29

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention