BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS ASCENDRA BALLOON CATHETER

    MDR report key: 3071416 · Received April 22, 2013

    Report

    Report Number
    2015691-2013-19876
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE DEVICE'S INSTRUCTIONS FOR USE (IFU) COMPLICATIONS ASSOCIATED WITH BALLOON AORTIC VALVULOPLASTY (BAV) AND TRANSCATHETER VALVE REPLACEMENT INCLUDE, BUT ARE NOT LIMITED TO, INJURY TO THE MITRAL VALVE. PER THE IFU, DIFFICULTY CROSSING THE NATIVE VALVE MAY BE DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS, INCLUDING HEAVY CALCIFICATION, WIRE BIAS INTO COMMISSURES, HORIZONTAL AORTA, TORTUOUS THORACIC AORTA, FLEX CATHETER KINKED, AND INCOMPLETE BAV. IN MOST INSTANCES THIS RESOLVES WITH ROUTINE TROUBLESHOOTING MANEUVERS, WITH MINIMAL RISK TO THE PATIENT. A CHORDAE TENDINAE RUPTURE DURING TAVR CAN OCCUR DURING ADVANCEMENT OF THE GUIDEWIRE, BAV CATHETER, OR DELIVERY SYSTEM AND IS MOST LIKELY TO OCCUR WITH THE TRANSAPICAL APPROACH. THE ASCENDRA PROCEDURAL TRAINING MANUAL INDICATES THAT DURING THE CASE THE GUIDEWIRE SHOULD BE JIGGLED UNDER TEE IMAGING OF THE MITRAL VALVE. IT CAUTIONS THAT AN INCREASE IN MR OR DECREASE IN MITRAL LEAFLET MOBILITY SUGGESTS WIRE ENTANGLEMENT IN THE MITRAL SUB-VALVULAR APPARATUS. IF ENTANGLEMENT IS SUSPECTED THE GUIDEWIRE SHOULD BE REMOVED FROM THE VENTRICLE, THE DIRECTION OF THE WIRE SHOULD BE CHANGED, AND TO THEN REINSERT THE GUIDEWIRE INTO THE VENTRICLE CHECKING AGAIN FOR WIRE ENTANGLEMENT. IN THIS CASE, IT IS POSSIBLE PROCEDURAL FACTORS (ENTANGLEMENT OF THE GUIDEWIRE ON THE MITRAL VALVE DURING BAV AND WHILE TRACKING THE DELIVERY SYSTEM WITH THE CRIMPED VALVE) LED TO THE REPORTED CROSSING DIFFICULTY AND CHORDAE RUPTURE. THERE IS NO EVIDENCE THAT SUGGESTS THE ASCENDRA DELIVERY DEVICE MALFUNCTIONED. THE IFU AND EDWARDS THV PATIENT SCREENING 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 PREVENTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSAPICAL TAVR CASE THERE WAS DIFFICULTY CROSSING THE NATIVE ANNULUS WITH THE ASCENDRA DELIVERY SYSTEM AND A RUPTURE OF THE MITRAL VALVE CHORDAE TENDINAE. THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS (CPB) AND THE CASE WAS CONVERTED TO OPEN HEART PROCEDURE TO REPAIR THE MITRAL VALVE AS IT NOW SHOWED SEVERE MITRAL REGURGITATION (MR) DUE TO THE DAMAGE OF THE CHORDAE. THE PATIENT WAS STABLE AND THE REPAIR COMPLETED BY THE CTS. THE PATIENT WAS TAKEN TO CVICU TO RECOVER. PER REPORT, DURING THE CASE THE 20X3MM EDWARDS BAV WAS INSERTED FOR THE BAV PROCEDURE. ALTHOUGH THERE WAS SOME DIFFICULTY IN CROSSING THE BALLOON THE BAV WAS SUCCESSFULLY COMPLETED. THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS WATCHED DURING THE BAV FOR ANY CHANGES AND NONE WERE NOTED. UPON ADVANCING THE 26MM SAPIEN VALVE ACROSS THE VALVE, THERE SEEMED TO BE A LOT OF RESISTANCE. THE CTS PULLED THE SAPIEN BACK AND TEE WAS CHECKED TO VERIFY THE POSITION AND AGAIN THE WIRE POSITION. NO CHANGES IN HEMODYNAMICS OR MITRAL REGURGITATION WERE NOTED AT THIS POINT. THE CTS ADJUSTED THE ANGLE OF THE SAPIEN AND RE-ADVANCED AGAIN WITH RESISTANCE. AGAIN THE CTS PULLED BACK TO CHECK TEE AND HEMODYNAMICS; NO CHANGE STILL. IT APPEARED THE CTS ADVANCED THE SHEATH AND THE SAPIEN AT THE SAME TIME TOWARDS THE NATIVE VALVE AND THE SAPIEN CROSSED AT THIS POINT. IMMEDIATELY THERE WAS A NOTICEABLE CHANGE IN THE PA PRESSURE AND TEE CONFIRMED THERE WAS A DAMAGED MITRAL VALVE CHORDAE. AT THIS POINT IT WAS DECIDED TO CONTINUE WITH THE IMPLANT OF THE SAPIEN. IT WAS PLACED IN THE ANNULUS IN A 60:40 (AORTIC POSITION) WITHOUT ANY LEAKS. THE MEDICAL TEAM IN THIS CASE DISCUSSED THE POSSIBLE ROOT CAUSE FOR THE CHORDAE RUPTURE. IT WAS EITHER THE WIRE WAS BEHIND A CHORDAE TENDINAE OR THE VALVE WAS CAUGHT ON A CHORDAE, WITHOUT THE WIRE BEING BEHIND THE CHORDAE. IT WAS NOT CLEAR ON FLUOROSCOPY OR TEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172468 EDWARDS ASCENDRA BALLOON CATHETER AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100BCL26 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention