BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U

    MDR report key: 10658814 · Received October 9, 2020

    Report

    Report Number
    2015691-2020-13924
    Event Type
    Injury
    Date Received
    October 9, 2020
    Date of Event
    September 15, 2020
    Report Date
    September 15, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THV/TVT REGISTRY THE COMMANDER DELIVERY SYSTEM WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. DIFFICULTY CROSSING THE NATIVE VALVE MAY BE DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS, INCLUDING HEAVY CALCIFICATION, WIRE BIAS INTO COMMISSURE, HORIZONTAL AORTA (TF), TORTUOUS THORACIC AORTA, FLEX CATHETER KINKED, INCOMPLETE BAV, OR INTERACTION WITH OTHER CARDIAC STRUCTURES (E.G. MITRAL VALVE ENTANGLEMENT DURING TA APPROACH). IN MOST INSTANCES THIS RESOLVES WITH ROUTINE TROUBLESHOOTING MANEUVERS, WITH MINIMAL RISK TO THE PATIENT. PER THE TRAINING MANUAL, FACTORS THAT CAN MAKE IT DIFFICULT TO CROSS INCLUDE ¿HEAVY CALCIFICATION¿ AND ¿INADEQUATE BAV¿. PER IFU AND TRAINING MANUALS DURING VALVE ALIGNMENT A GAP BETWEEN THE THV AND DISTAL VALVE ALIGNMENT MARKER MAY RESULT IN DIFFICULTY CROSSING. AN OVERLAP CANNOT BE REVERSED AND MAY PREVENT PROPER THV DEPLOYMENT. DO NOT BEND OR APPLY TORQUE TO THE PROXIMAL END OF THE BALLOON CATHETER THROUGHOUT THE PROCEDURE. DO NOT POSITION THV PAST THE DISTAL VALVE ALIGNMENT MARKER. THIS WILL PREVENT PROPER THV DEPLOYMENT. COMPRESSION MAY BE OBSERVED IN THE DISTAL PORTION OF THE FLEX CATHETER DURING VALVE ALIGNMENT. DIVING MAY BE OBSERVED BETWEEN THE THV AND THE FLEX CATHETER TIP DURING VALVE ALIGNMENT. TO CORRECT, MOVE TO A DIFFERENT STRAIGHT SECTION OF THE AORTA (FOR DIVING ONLY). IF USING THE BALLOON CATHETER, PUSH FORWARD SLIGHTLY, AND THEN CONTINUE PULLING BACK UNTIL PART OF WARNING MARKER IS VISIBLE. IF USING THE FINE ADJUSTMENT WHEEL, REVERSE AND THEN CONTINUE WITH FINE ADJUSTMENT UNTIL THV IS CENTERED EXACTLY BETWEEN THE VALVE ALIGNMENT MARKERS. THV MOVES IN ONLY ONE DIRECTION RELATIVE TO THE BALLOON. PERFORM VALVE ALIGNMENT IN THE STRAIGHT SECTION OF THE AORTA. WHEN EXPERIENCING DIFFICULTY CROSSING: MAKE SURE WIRE IS CORRECTLY EXTENDED AT APEX, PULL TENSION ON THE WIRE OR REPOSITION, ADD SOME DISTAL FLEX OR REMOVE SOME PARTIAL FLEX, PULL SYSTEM BACK AND RE-ADVANCE. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES, INCLUDING PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE SEVERAL POTENTIAL ETIOLOGIES FOR VENTRICULAR PERFORATION DURING A TAVR PROCEDURE, INCLUDING PERFORATION BY THE GUIDEWIRE, THE DELIVERY SYSTEM, OR THE TRANSVENOUS PACER (TVP) LEAD. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PROPER GUIDEWIRE POSITIONING, FIXATION OF THE TVP TO PREVENT VENTRICLE PERFORATION, AND CAREFUL MANIPULATION OF DEVICES. PER THE PROCEDURE DIDACTIC, PATIENTS WITH SMALL VENTRICLES ARE AT PARTICULARLY HIGH RISK FOR VENTRICULAR PERFORATION. IN THIS CASE, THERE WAS NO INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS EVENT. PATIENT FACTORS (HORIZONTAL AORTA AND CALCIUM) AND PROCEDURAL FACTORS (NOT PERFORMING BAV) LIKELY CONTRIBUTED TO THE DIFFICULTY CROSSING THE NATIVE ANNULUS AND RESULTING VENTRICULAR PERFORATION BY THE DELIVERY SYSTEM NOSE CONE AND GUIDEWIRE. 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

    DURING IMPLANT OF A 26MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION USING TRANSFEMORAL APPROACH, THE WIRE WAS ACCIDENTALLY PULLED OUT WHILE THE VALVE AND DELIVERY SYSTEM WERE IN THE PATIENT. THE DEVICES WERE WITHDRAWN, AND A NEW VALVE AND DELIVERY SYSTEM WERE PREPARED. WHILE CROSSING THE AORTIC VALVE WITH THE SECOND VALVE AND DELIVERY SYSTEM, THERE WAS RESISTANCE AND DIFFICULTY CROSSING DUE TO THE PATIENT¿S HORIZONTAL ARCH AND CALCIUM. THE BUILT-UP FORWARD PRESSURE ON THE DELIVERY SYSTEM GAVE WAY AND THE DEVICES JUMPED ACROSS THE AORTIC VALVE WITH FORCE INTO THE LEFT VENTRICLE. THE NOSE CONE OF THE DELIVERY SYSTEM ON THE WIRE WERE PUSHED INTO THE APEX OF THE HEART, CAUSING A PERICARDIAL EFFUSION. THE BLEEDING WAS NOT NOTICED UNTIL THE ACCESS SITE WAS CLOSED AND THE FINAL ECHO WAS PERFORMED. THE EFFUSION WAS DRAINED. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING FINE. BAV WAS NOT PERFORMED AS THE PATIENT¿S AORTA WAS HORIZONTAL AND THERE WAS MORE OF AN ANGLE PROBLEM THAN A CALCIUM PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119202 EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750CM26A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention