BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 6012046 · Received October 7, 2016

    Report

    Report Number
    2015691-2016-02976
    Event Type
    Death
    Date Received
    October 7, 2016
    Date of Event
    September 14, 2016
    Report Date
    September 14, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION 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 AORTIC DISSECTION, HEMATOMA OR ANNULAR RUPTURE DURING THE TAVR PROCEDURE INCLUDE SIGNIFICANT THV OVER SIZING, SEVERELY OBLITERATED SINUSES OF VALSALVA, PORCELAIN AORTA AND/OR PRESENCE OF BULKY CALCIFICATION AND NARROW CALCIFIED STJ. IN ADDITION, ADVANCED AGE, FEMALE GENDER, SMALL BODY WEIGHT, AND STEROID DEPENDENCY CAN ALSO BE CONTRIBUTING FACTORS. 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. IN THIS CASE, THE HEAVILY CALCIFIED AORTIC ROOT MOST LIKELY CAUSED OR CONTRIBUTED TO THE ANNULAR RUPTURE. 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 BY THE EDWARDS EUROPEAN AFFILIATE, AFTER THE IMPLANT OF A 29MM SAPIEN 3 VALVE, BY TF APPROACH IN AORTIC POSITION, THE FIRST ANGIOGRAPHY SHOWED A SMALL CONTRAST SPRAY INTO THE AORTIC ROOT. BLOOD PRESSURE WAS STILL REGULAR WHILE CLOSING MANEUVERS WERE BEING PERFORMED. AT THIS POINT A SUDDEN HYPOTENSION OCCURRED WITH A SUBSEQUENT ARREST. INOTROPES WERE ADMINISTERED AND CPR MANEUVERS WERE PERFORMED. TTE SHOWED A PERICARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS SUCCESSFUL PERFORMED WITH COMPLETE BLOOD DRAINAGE, BUT LV FUNCTION WAS, AT THAT POINT, SEVERELY DAMAGED AND UNLUCKILY THE PATIENT PASSED AWAY SHORT AFTER. THE PERCEIVED ROOT CAUSED OF THE PERICARDIAL TAMPONADE WAS CAUSED VERY PROBABLY BY A SMALL RUPTURE IN A HEAVILY CALCIFIED AORTIC ROOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661835 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX29 4607850

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death