BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS TRANSFEMORAL BALLOON CATHETER

    MDR report key: 4974230 · Received August 5, 2015

    Report

    Report Number
    2015691-2015-01982
    Event Type
    Death
    Date Received
    August 5, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 16, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 PATIENT¿S MODERATE LEAFLET CALCIFICATION, ADVANCED AGE AND FEMALE GENDER ARE LIKELY CONTRIBUTING FACTORS FOR 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 THROUGH THE THV HOTLINE, DURING A TRANSFEMORAL TAVR PROCEDURE, BAV WAS PERFORMED WITH AN EDWARDS 23X4 BALLOON. THE PATIENT APPEARED TO TOLERATE THE BAV AND THE VALVE AND DELIVERY SYSTEM WERE INSERTED INTO THE ESHEATH. THE PATIENT¿S PRESSURE DROPPED AND ECHO (TEE) REVEALED A PERICARDIAL EFFUSION AND CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND THERE APPEARED TO BE A CONTAINED HEMATOMA AT THE LEVEL OF THE ANNULUS IN THE AORTA. THE PATIENT BEGAN TO DECOMPENSATE AND WAS PLACED ON CARDIOPULMONARY SUPPORT (CPS). THE PATIENT¿S PRESSURE WAS DROPPING AT 40MMHG AND A TEMPORARY PACER WAS UTILIZED AT 80 BPM. THE PATIENT¿S PRESSURE CONTINUED TO DROP AND CPR WAS INITIATED. THE PHYSICIANS DECIDED TO DEPLOY A 26MM SAPIEN XT VALVE IN AN ATTEMPT TO SEAL THE ANNULAR RUPTURE. ECHO SHOWED THE VALVE WAS OK, BUT THE PATIENT NEVER RECOVERED AND EXPIRED ON THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514523 EDWARDS TRANSFEMORAL BALLOON CATHETER AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9350BC23

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death