BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 6012903 · Received October 7, 2016

    Report

    Report Number
    2015691-2016-02987
    Event Type
    Death
    Date Received
    October 7, 2016
    Date of Event
    July 25, 2016
    Report Date
    July 25, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) REGISTRY. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR COMPLICATIONS, INCLUDING PERFORATION OR DISSECTION OF VESSELS WHICH MAY REQUIRE INTERVENTION, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. THE DEVICE (AND/OR APPLICABLE IMAGERY) WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. REVIEW OF COMPLAINT HISTORY FROM OCTOBER 2015 TO SEPTEMBER 2016 REVEALED NO OTHER SIMILAR RETURNED COMPLAINTS WHERE AN XT VALVE WAS MOUNTED ON A COMMANDER DELIVERY SYSTEM AND ATTEMPTED TO BE RETRIEVED THROUGH A 14FR ESHEATH. A REVIEW OF THE IFU AND TRAINING MANUALS WAS PERFORMED. THE DEVICE PREPARATION MANUAL OUTLINES VISUAL INSPECTION FOR ANY DAMAGED COMPONENTS AND THE STEPS NEEDED FOR DEVICE PREP AND VALVE CRIMPING. THE IFU PROVIDES SPECIFIC INSTRUCTIONS TO VERIFY THE CORRECT ORIENTATION OF THE THV DURING DEVICE PREP AND CRIMPING OF THE VALVE. IN ADDITION, THE SAPIEN 3 IFU CAUTIONS THAT THE PHYSICIAN MUST VERIFY CORRECT ORIENTATION OF THE THV PRIOR TO ITS IMPLANTATION; ITS INFLOW (FABRIC CUFF END) SHOULD BE ORIENTED DISTALLY TOWARDS THE TAPERED TIP. THE FABRIC CUFF IS A DESIGN FEATURE SPECIFIC FOR THE SAPIEN 3. THE SAPIEN XT VALVE DOES NOT HAVE THIS FEATURE, AND WOULD BE IDENTIFIED DURING THIS STEP. IT WAS REPORTED THAT A 23MM SAPIEN XT VALVE WAS INADVERTENTLY CRIMPED ON A 23MM COMMANDER DELIVERY SYSTEM IN ERROR, AND THE VALVE ALIGNMENT PROCESS WAS STARTED PRIOR TO ATTEMPTING RETRIEVAL. THE FOLLOWING INFORMATION WAS NOTED FROM TRAINING: - THE SAPIEN XT VALVE IS NOT INDICATED FOR USE WITH THE COMMANDER DELIVERY SYSTEM. - PER IFU/TRAINING, ADVANCEMENT AND RETRIEVAL OF THE 23MM XT VALVE THROUGH A 14FR ESHEATH IS NOT INDICATED. THE 23MM XT VALVE IS INDICATED TO BE USED WITH THE 16FR ESHEATH PER NOVAFLEX/ESHEATH TRAINING. - THE CLINICAL TEAM INVOLVED UNDERSTOOD THAT THIS VALVE WAS INCOMPATIBLE WITH THE DELIVERY SYSTEM/SHEATH AND RECOGNIZED THAT THIS ACTION WAS PERFORMED IN ERROR ONCE THE VALVE WAS ALREADY IN THE PATIENT. - PER AVAILABLE TRAINING, THE FOLLOWING INFORMATION IS ALSO PROVIDED FOR GUIDANCE WHEN ATTEMPTING TO RETRIEVE A THV VALVE INTO THE ESHEATH: ¿CRIMPED THV ALIGNED ON BALLOON IS LARGER THAN CRIMPED THV OFF BALLOON. TAKE CARE IF DECIDING TO RETRIEVE.¿ 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.

    Description of Event or Problem · 1

    DURING A TRANSFEMORAL TAVR PROCEDURE, USE ERROR LED TO A DESCENDING AORTIC DISSECTION. A 14 FR ESHEATH WAS INSERTED INTO THE RIGHT FEMORAL ARTERY (RFA) WITHOUT INCIDENT. A BAV, WITH AN EDWARDS 20 MM X 4 CM, WAS PERFORMED WITH RVP AT 180 BPM. THE 23 MM THV AND COMMANDER DELIVERY SYSTEM WERE PREPPED WITH NOMINAL VOLUME. THE DELIVERY SYSTEM WAS INSERTED INTO THE 14F ESHEATH AND THE VALVE WAS ALIGNED OVER THE BALLOON IN THE DESCENDING AORTA. DURING ALIGNMENT, IT WAS NOTED THAT THE PROXIMAL MARKER ON THE BALLOON WAS COMPLETELY OUT OF THE VALVE. AT THAT TIME IT WAS APPARENT THAT A SAPIEN XT, NOT A SAPIEN 3, HAD BEEN PLACED ON THE COMMANDER DELIVERY SYSTEM DURING PREP. THE PHYSICIAN ATTEMPTED TO REMOVE THE XT VALVE AND DELIVERY SYSTEM BY WITHDRAWING THE PROXIMAL PORTION OF THE BALLOON INTO THE SHEATH AND SLIGHTLY INFLATING TO EXPAND THE DISTAL TIP. THE GOAL WAS TO WITHDRAW THE THV-DELIVERY SYSTEM INTO THE SHEATH AND REMOVE THE ENTIRE SYSTEM. THIS APPROACH WAS UNSUCCESSFUL. THE HEART TEAM AGREED IT WAS APPROPRIATE TO DEPLOY THE XT VALVE IN THE ABDOMINAL AORTA. THE VALVE WAS SLOWLY DEPLOYED IN THE ABDOMINAL AORTA WITHOUT ISSUE. AN ABDOMINAL AORTOGRAM, REVEALED AN AORTIC DISSECTION WITH REDUCTION IN BLOOD PRESSURE. THE VASCULAR TEAM WAS CONSULTED FOR INTERVENTION. THE VASCULAR SURGEON PLACED TWO ENDOGRAFTS: ONE IN THE XT VALVE AND ONE THAT EXTENDED INTO THE RIGHT COMMON ILIAC ARTERY. AFTER DEPLOYMENT OF THE ENDOGRAFTS, THE AORTOGRAM REVEALED GOOD BRISK FLOW IN THE ABDOMINAL AORTA (NO DISSECTION), BUT NO FLOW WAS NOTED DOWN THE LEFT COMMON ILIAC ARTERY. AT THIS TIME, THE PATIENT WAS HEMODYNAMICALLY STABLE AND THE VASCULAR TEAM FELT IT WAS APPROPRIATE TO TRANSFER THE PATIENT TO THE OR FOR A LEFT FEM-FEM BYPASS. ON POST-OPERATIVE DAY (POD) 2 THE PATIENT WAS REPORTED TO BE AWAKE AND ALERT WITH NO VASOPRESSORS. THE PATIENT PASSED AWAY ON POD- 8. THE CAUSES OF DEATH LISTED ON THE DEATH CERTIFICATE ARE: MULTI-ORGAN FAILURE, HYPOTENSION AND AORTIC RUPTURE. THE PERCEIVED CAUSE WAS OVERSIGHT ON MULTIPLE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662008 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600LDS23

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death