BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U

    MDR report key: 10266052 · Received July 13, 2020

    Report

    Report Number
    2015691-2020-12499
    Event Type
    Death
    Date Received
    July 13, 2020
    Date of Event
    June 18, 2020
    Report Date
    June 18, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. 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. 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 3 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, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT.  THE CAUSE OF THE AORTIC DISSECTION COULD NOT BE CONFIRMED, HOWEVER, IT MAY BE RELATED TO PROCEDURAL FACTORS (DEVICE MANIPULATION). 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 FROM OUR AFFILIATES IN (B)(4), DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 20MM SAPIEN 3 ULTRA VALVE IN A PREVIOUSLY IMPLANTED IN A 21MM NON-EDWARDS VALVE IN AORTIC POSITION. THE VALVE WAS SUCCESSFULLY IMPLANTED WITH AND NO LEAK BUT THE GRADIENT WAS >20MM HG.  THE VALVE WAS NOTED TO BE UNDER-EXPANDED. THERE WAS NO DIFFICULTIES FOUND DURING TRACKING THROUGH THE VESSELS OR AORTA. POST DILATATION WITH NOMINAL VOLUME WAS PERFORMED. THE PATIENT¿S BLOOD PRESSURE DROPPED PRIOR TO POST-DILATATION.  THE DELIVERY SYSTEM WAS REMOVED AND AN IMPELLA HEART PUMP WAS PLACED. AS THE LM WAS LOW, IT WAS PRE-WIRED WITH A BALLOON. IT WAS ASSUMED THAT THIS WAS THE PROBLEM. REANIMATION (CARDIAC MASSAGE) AND BALLOONING OF THE LM HAD NO EFFECT. AFTER 30 MIN. OF REANIMATION, IT WAS NOTED THAT THERE WAS AN AORTIC DISSECTION AT THE BEGINNING OF THE ARCH CURVATURE, AND A PNEUMOTHORAX BLEEDING WAS IDENTIFIED, MAY BE DUE TO ADVANCING FOR THE POST DILATION (AS TIMING SUGGESTS) BUT NOT CLEAR HOW. THE PATIENT EXPIRED. AFTER IMAGING REVIEW, SOME CALCIFICATION IN THE CURVATURE OF THE AORTIC ARCH WHERE THE DISSECTION OCCURRED WERE OBSERVED.  IN PHYSICIAN¿S OPINION, IT IS HIGHLY POSSIBLE THAT THEY SCRATCHED ONE AWAY WITH THE PUSHER OF THE DELIVERY SYSTEM WHEN ADVANCING TO THE VALVE TO POST-DILATE. FROM THAT MOMENT THERE WAS NO WAY TO SAVE THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731991 EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES COMMANDER DELIVERY SYSTEM 62538026

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death