BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 23MM

    MDR report key: 3983473 · Received August 6, 2014

    Report

    Report Number
    2015691-2014-01792
    Event Type
    Death
    Date Received
    August 6, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. IN THIS CASE THE EXACT CAUSE OF THE ANNULAR RUPTURE COULD NOT BE CONFIRMED; HOWEVER, SEVERE BULKY CALCIFICATION OF THE AORTIC VALVE AND ROOT ARE RISK FACTORS FOR ANNULAR RUPTURE AND LIKELY CONTRIBUTED TO THE REPORTED 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

    IMMEDIATELY AFTER TRANSFEMORAL DEPLOYMENT OF A 23MM SAPIEN XT VALVE, THE PATIENT LOST CARDIAC OUTPUT. CPR AND CARDIOPULMONARY BYPASS WERE INITIATED BUT THE PATIENT COULD NOT RECOVER HEMODYNAMIC STABILITY. RESUSCITATIVE MEASURES WERE STOPPED AND THE PATIENT EXPIRED. AS REPORTED, AN UNEVENTFUL BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH THE 20 X 3 EDWARDS BAV BALLOON. THE POSTMORTEM EXAMINATION REVEALED NO EVIDENCE OF LEFT VENTRICULAR (LV) PERFORATION. THE PROSTHETIC VALVE WAS WELL POSITIONED, INTACT, NO PROBLEM WAS NOTED. HOWEVER, A SMALL TEAR WAS FOUND (WHICH WAS ACTUALLY A PERFORATION) IN THE AORTA JUST BELOW LEFT CORONARY, ONLY 2MM LONG, WHICH COMMUNICATED WITH THE PERICARDIAL SPACE WITH BLEEDING EXTENDING INTO TISSUE IN THE MEDIASTINUM. AS DESCRIBED, A FORM OF ANNULAR RUPTURE RATHER THAN AORTIC DISSECTION. THERE WAS NO DISSECTION IN ASCENDING AORTA OR ARCH. PER REPORT, BASED ON THE TIMING OF THE PATIENT¿S DETERIORATION, THIS PERFORATION/RUPTURE OCCURRED PROBABLY WHEN THE VALVE WAS DEPLOYED. THE NATIVE AORTIC VALVE AND ROOT WERE SEVERELY (BULKY) CALCIFIED. THE SINOTUBULAR JUNCTION (STJ) DIAMETER WAS 28MM, AND THE SINUS OF VALSALVA (SOV) DIAMETER WAS 31MM. THE IMAGE INTENSIFIER ANGLE AND THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WERE BOTH DESCRIBED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459664 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 23MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death