BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS ASCENDRA+ INTRODUCER SHEATH

    MDR report key: 7693791 · Received July 17, 2018

    Report

    Report Number
    2015691-2018-02858
    Event Type
    Death
    Date Received
    July 17, 2018
    Date of Event
    March 23, 2017
    Report Date
    March 25, 2017
    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 · 0

    REFERENCE CAPA-20-00141.

    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, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE PROCEDURAL FACTORS (CHANGE OF THE ANGLE OF SHEATH AFTER TOUCHING THE SEPTUM, PLACEMENT OF PURSE STRING SUTURES) LIKELY CONTRIBUTED TO THE INITIAL APEX TEAR DURING THE INSERTION OF THE SHEATH. THE APEX TEAR MAY HAVE CONTRIBUTED TO THE POST PROCEDURAL PSEUDOANEURYSM, HEART FAILURE AND SUBSEQUENT PATIENT DEATH WHEN THE PSEUDOANEURYSM RUPTURED. 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 OUR AFFILIATE IN (B)(6) AND THROUGH THE JAPANESE TAVI CASE REGISTRY, DURING A TRANSAPICAL TAVR PROCEDURE, DURING THE INSERTION OF AN ASCENDRA SHEATH, THE HEART MUSCLE WAS TORN. AN ADDITIONAL STITCH SUCCESSFULLY STOPPED THE BLEEDING. A 23 MM SAPIEN XT VALVE WAS IMPLANTED. NO BLOOD TRANSFUSION WAS REQUIRED FOR THE EVENT. THE PATIENT WAS TRANSFERRED TO THE CCU IN STABLE CONDITION. POST PROCEDURE, THE PATIENT DEVELOPED HEART FAILURE. NON-INVASIVE POSITIVE PRESSURE VENTILATION (NPPV) WAS IMPLEMENTED. THE PATIENT¿S CCU STAY WAS EXTENDED FOR A ¿LONG PERIOD OF TIME¿. RESPIRATORY FUNCTION WAS IMPROVING AND THE PATIENT RECOVERED ENOUGH TO CONSUME FOODS BY MOUTH. THE PATIENT WAS TRANSFERRED TO THE GENERAL WARD. AT THIS POINT, POST-PROCEDURAL CT CONFIRMED A PSEUDOANEURYSM ON THE APEX. SINCE THE PATIENT HAD RECEIVED A TAVR VALVE, AND DUE TO THE PATIENT¿S ADVANCED AGE, THE TREATMENT PLAN WAS TO BE DETERMINED ONCE THE PATIENT¿S CONDITION STABILIZED. ON POSTOPERATIVE DAY (POD) 16, THE PATIENT COMPLAINED OF CHEST PAIN AND LOST CONSCIOUSNESS. THE PATIENT THEN LAPSED INTO CARDIOPULMONARY ARREST. THE PSEUDOANEURYSM ON THE APEX HAD RUPTURED. CT CONFIRMED ¿MASSIVE¿ AMOUNT OF FLUIDS IN THE LEFT THORACIC CAVITY. ALTHOUGH PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WAS IMPLEMENTED, FLOW VOLUME COULD NOT BE MAINTAINED. RESUSCITATION WAS STOPPED AND THE PATIENT PASSED AWAY THAT DAY. INFORMATION REGARDING THE NATIVE ANNULAR DIAMETER AND THE DEGREE OF VALVULAR CALCIFICATION WAS NOT PROVIDED. PER MEDICAL OPINION, THE ANGLE OF THE SHEATH WAS ACCIDENTALLY CHANGED WHEN THE TIP OF THE SHEATH TOUCHED THE SEPTUM, CAUSING THE APEX TEAR. THE PURSE STRING SUTURES MAY HAVE BEEN BETTER PLACED IN AN AREA CLOSER TO THE ANTERIOR WALL SIDE SINCE THE RIGHT SIDE OF THE HEART WAS TAUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536783 EDWARDS ASCENDRA+ INTRODUCER SHEATH AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9350IS23J 60415995

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R