BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM, 26MM

    MDR report key: 4919675 · Received July 16, 2015

    Report

    Report Number
    2015691-2015-01727
    Event Type
    Death
    Date Received
    July 16, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 23, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. ASCENDING AORTIC DISSECTION MAY OCCUR WHEN MULTIPLE ATTEMPTS ARE MADE TO CROSS THE STENOTIC NATIVE VALVE, AND/OR WHEN EXCESSIVE FORCE IS USED. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVE (THV). THE THV TRAINING MANUALS PROVIDE GUIDANCE TO FACILITATE SAFE CROSSING OF THE NATIVE VALVE, INCLUDING CAMERA PROJECTIONS, HANDLING DURING ADVANCEMENT, AND TROUBLESHOOTING TECHNIQUES IF DIFFICULTY IS ENCOUNTERED. AS STATED, EXCESSIVE FORCE SHOULD NOT BE USED WHEN THE DEVICE HAS DIFFICULTY CROSSING THE STENOTIC VALVE. ADDING TENSION TO THE WIRE, PULLING BACK THE SYSTEM TO RE-ORIENT THE VALVE, AS NEEDED, AND TORQUING OF THE FLEX CATHETER MAY BE HELPFUL IN SOLVING THE PROBLEM. IN THIS CASE, PER REPORT, THE PATIENT¿S ANATOMY (AORTA TORTUOSITY, ATHEROSCLEROTIC CALCIUM) APPEARS TO HAVE CONTRIBUTED TO THE EVENT. 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

    Additional Manufacturer Narrative · 1

    PRE-PROCEDURAL CT AND PROCEDURAL CINE IMAGES AND WERE SUBMITTED FOR REVIEW. THE FOLLOWING OBSERVATIONS AND IMPRESSION WERE MADE BY AN EDWARDS PHYSICIAN PROCTOR. OBSERVATIONS: CINE: HEAVILY CALCIFIED LEAFLETS, NO CALCIUM IN AORTA OR STJ. BAV PERFORMED WITH STANDARD WIRE IN LV GOOD COAXIAL ALIGNMENT; GOOD BAV (WELL DONE) NO IMAGES AVAILABLE AFTER BAV UNTIL DS IS ALREADY COMPLETELY ADVANCED THROUGH THE AORTA TWO KINKS ARE NOTED ON THE DELIVERY SYSTEM IN AORTA; DS KINK IN DESCENDING AORTA IS SEVERE. KINKED AREA OF DS APPEARS TO BE INSIDE THE AORTIC DISSECTION. DISSECTION RUNS RETROGRADE FROM DESCENDING AORTA THROUGH THE AORTIC ARCH TO THE ASCENDING AORTA. CT: NO SIGNIFICANT CALCIUM NOTED THROUGH AORTA. IMPRESSIONS: THE CT SCAN SHOWS NORMAL ANGULATION IN DESCENDING AORTA. THE PIGTAIL CATHETER SHOWS NORMAL POSITIONING. BAV APPEARS STRAIGHT, NO TORTUOSITY NOTED. LAST IMAGE WITH S3 IMPLANTED SHOWS RETROGRADE DISSECTION. NO KINKING IN AORTA NOTED WITH AORTOGRAM. THE DS KINKED AS A RESULT OF THE DEVICE MANIPULATION INTERACTING WITH DESCENDING AORTA UPON ADVANCEMENT. KNOWN INHERENT RISK OF PROCEDURE.

    Description of Event or Problem · 1

    AS REPORTED BY OUR ITALIAN AFFILIATE, THE PATIENT DIED FROM A COMPLICATION OF AN AORTIC DISSECTION DURING AN IMPLANT OF A 26MM SAPIEN 3 VALVE. AS REPORTED, AFTER BALLOON VALVULOPLASTY (BAV) DIFFICULTY IN ADVANCING THE DELIVERY SYSTEM ON THE GUIDEWIRE WAS NOTED. SUDDENLY THE PATIENT BECAME HYPOTENSIVE AND CPR MANEUVERS WERE PERFORMED. THE GUIDEWIRE CAME OUT OF THE VENTRICLE AND THE VALVE WAS DELIVERED IN THE DESCENDING AORTA. THE ANGIOGRAM REVEALED A DISSECTION THAT AFFECTED THE ENTIRE ASCENDING AORTA FROM THE VALVE PLANE TO THE AORTIC ARCH AND TO THE DESCENDING AORTA. IT WAS THOUGHT THAT THE DISSECTION MAY HAVE ORIGINATED FROM THE DESCENDING AORTA AND PROGRESSED FROM THAT POINT. AS PER REPORT, THE DELIVERY SYSTEM MAY HAVE CAUGHT AN ATHEROSCLEROTIC PLAQUE DURING ADVANCEMENT. AS PER THE MEDICAL TEAM, A DEVICE MALFUNCTION WAS NOT THE CAUSE OF THE EVENT AND THE TORTUOUS ANATOMY MAY HAVE CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462185 EDWARDS COMMANDER DELIVERY SYSTEM, 26MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9610TF26 59997692

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| R