BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 23MM

    MDR report key: 3984248 · Received August 6, 2014

    Report

    Report Number
    2015691-2014-01797
    Event Type
    Death
    Date Received
    August 6, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    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 CAUSE OF THE ANNULAR RUPTURE CANNOT BE CONFIRMED; HOWEVER, AS PER REPORT THE VALVE MAY HAVE BEEN OVERSIZED AND CONFLICTING IMAGES 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

    THE PATIENT DIED FROM A COMPLICATION OF AN ANNULAR RUPTURE DURING A TRANSFEMORAL DEPLOYMENT OF A SAPIEN XT 23MM VALVE. AS REPORTED, DURING THE TEE ASSESSMENT FOR PARAVALVULAR LEAK (PVL) AND CENTRAL AORTIC REGURGITATION (CAI) THE PATIENT WAS EXPERIENCING A SIGNIFICANT AMOUNT OF PREMATURE VENTRICULAR CONTRACTIONS (PVC) AND THE PHYSICIAN TEAM DECIDED TO REMOVE THE .035" AMPLATZ EXTRA SUPPORT WIRE FROM THE LEFT VENTRICLE (LV). MINIMAL PVL WAS NOTED AND WITH REMOVAL OF THE WIRE THE CAI RESOLVED. HOWEVER, WITHIN MOMENTS OF REMOVING THE WIRE FROM THE LV, THE PATIENT¿S BLOOD PRESSURE DROPPED TO 30MMHG AND A LARGE PERICARDIAL EFFUSION WAS NOTED. CPR WAS INITIATED AND A BYPASS CANNULA WAS INTRODUCED. THE ACCESS ON THE RIGHT FEMORAL ARTERY (RFA) WAS LOST AND AN ATTEMPT TO PLACE A CANNULA FROM THE LEFT FEMORAL ARTERY (LFA) RESULTED IN A LACERATED LFA. DURING BYPASS, A SECOND ATTEMPT AT A PERICARDIAL TAP WAS UNSUCCESSFUL. AN OPEN STERNOTOMY WAS PERFORMED; THE PATIENT WAS PLACED ON BYPASS AND THE SURGEON NOTED THAT THE PERFORATION WAS ALONG THE AV GROOVE OF THE HEART AND NOT AT THE APEX. BLEEDING WAS CONTROLLED AND BOTH THE RFA AND THE LFA WERE SURGICALLY REPAIRED. THE HEART WAS ADDRESSED AND IT WAS DETERMINED THAT THERE WAS AN ANNULAR RUPTURE THAT RAN FROM THE AV GROOVE UP TO THE AORTIC ROOT. THE VALVE WAS EXPLANTED AND ROOT REPLACEMENT WAS PERFORMED. THE PATIENT RECEIVED 16 UNITS OF RED BLOOD CELLS (RPC) AND 4 UNITS OF PLASMA (FFP) DURING THE COURSE OF THIS EVENT. AFTER COMPLETION OF THE ROOT REPAIR/VALVE REPLACEMENT THE PATIENT COULD NOT BE WEANED FROM BYPASS AND EXPIRED. THE NATIVE AORTIC VALVE AND ROOT WERE MILDLY CALCIFIED. THE SINOTUBULAR JUNCTION (STJ) DIAMETER WAS 21MM AND THE SINUS OF VALSALVA (SOV) DIAMETER WAS 25. THE IMAGE INTENSIFIER ANGLE AND THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WERE BOTH DESCRIBED AS GOOD. PER REPORT, THE VALVE WAS OVERSIZED AND THERE WAS CONFLICTING IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460960 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 23MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death