BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 4100067 · Received September 18, 2014

    Report

    Report Number
    2015691-2014-02177
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DAMAGE (DISSECTION) OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. ACCORDING TO THE THV TRAINING MANUALS, RISK FACTORS FOR ACUTE AORTIC RUPTURE/DISSECTION IN THE TAVR PROCEDURE INCLUDE SIGNIFICANT VALVE OVER SIZING (I.E. =4MM) IN THE PRESENCE OF SEVERELY CALCIFIED AORTIC ROOT AND OBLITERATED SINUSES. THE SAPIEN VALVE RELIES ON NATIVE VALVE CALCIUM TO SECURELY ANCHOR TO THE ANNULUS. DESPITE THIS BENEFICIAL ASPECT OF CALCIUM, BULKY CALCIUM CAN INCREASE THE RISK OF CALCIFIC NODULE DISPLACEMENT INTO THE VASCULATURE, WHICH CAN LEAD TO VASCULAR INJURY. AT TIMES THE EXTENT AND DISTRIBUTION OF CALCIUM CAN IMPAIR EASE OF DELIVERY OF THE VALVE, CORRECT POSITIONING OF THE VALVE, DEPLOYMENT OF THE VALVE AND PROCEDURAL SUCCESS. THE STANDARD NATIVE ANNULUS AREA FOR THE 23MM SAPIEN XT VIA CT IS 314MM2-415MM2. IN THIS CASE THE EXACT CAUSE OF THE ANNULAR RUPTURE COULD NOT BE DETERMINED. HOWEVER THE MODERATE CALCIFICATION OF THE NATIVE ANNULUS IN ADDITION TO THE BORDERLINE ANNULAR AREA OF THE NATIVE VALVE MAY 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. 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

    IT WAS REPORTED BY OUR (B)(4) AFFILIATE THAT POST DEPLOYMENT OF A 23MM SAPIEN XT VALVE, A PERICARDIAL EFFUSION WAS NOTED BY TEE. AN ANGIOGRAPHY REVEALED SOME LEAK OF CONTRAST FROM THE LEFT CORONARY CUSP (LCC) SIDE, WHICH WAS DETERMINED TO BE AN ANNULAR RUPTURE. THEREFORE, THE TAVR PROCEDURE WAS CONVERTED TO SURGICAL AORTIC VALVE REPLACEMENT (AVR). THE AVR WAS PERFORMED SUCCESSFULLY AND THE PATIENT¿S VITALS WERE STABLE POST AVR. THE PATIENT¿S NATIVE ANNULUS MEASURED 20MM WITH AN AREA OF 314 MM2. THE NATIVE VALVE WAS MODERATELY CALCIFIED WITH MILD ROOT CALCIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577843 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23J

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention