BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U

    MDR report key: 10693151 · Received October 16, 2020

    Report

    Report Number
    2015691-2020-14011
    Event Type
    Injury
    Date Received
    October 16, 2020
    Date of Event
    September 22, 2020
    Report Date
    September 22, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THE CAUSE OF THE AORTIC DISSECTION COULD NOT BE DETERMINED. HOWEVER, PATIENT FACTORS AND/OR THE MECHANISMS DESCRIBED ABOVE ARE LIKELY CONTRIBUTING FACTORS FOR 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 AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATES IN (B)(6), AFTER DEPLOYMENT OF 23MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION BY TRANSFEMORAL APPROACH, THE PATIENT BEGAN TO SHOW CLINICAL SIGNS OF CARDIAC TAMPONADE. ECHOCARDIOGRAPHY SHOWED A PERICARDIAL EFFUSION. PERICARDIOCENTESIS AND BLOOD ASPIRATION WAS PERFORMED, AND BLOOD WAS REINFUSED DIRECTLY THROUGH AN ARTERIAL LINE TO THE PATIENT. AS A RESULT, THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE ENTIRE COURSE OF EVENTS. AORTOGRAPHY AND VENTRICULOGRAPHY SHOWED A FISSURE AT AN UNSPECIFIED POINT IN THE AORTIC ROOT NEAR THE LEFT CUSP. SINCE THE EFFUSION DID NOT STOP SPONTANEOUSLY, A STERNOTOMY WAS PERFORMED AND HEMOSTASIS WAS OBTAINED BY APPLYING AN EXTERNAL PATCH. DURING AORTOGRAPHY, THE VALVE APPEARED CORRECTLY POSITIONED, WELL EXPANDED AND WITHOUT PARAVALVULAR LEAKAGE. THERE WERE NO ADVERSE EVENTS OR DEVICE MALFUNCTIONS OBSERVED DURING THE DEPLOYMENT. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE. AS PER MEDICAL OPINION, THERE WAS NO APPARENT REASON TO CONSIDER THE AORTIC ROOT AT RISK OF RUPTURE. THE NATIVE ANNULUS MEASURED 370MM2 AND HAD MILD TO MODERATE CALCIFICATION. THE PATIENT HAD A MILD DEGREE OF AORTIC TORTUOSITY. THERE WERE NO DIFFICULTIES NOTICED WHEN TRACKING OVER THE AORTIC ARCH. THE FLEX CATHETER WAS UNFLEXED DURING THE WITHDRAWAL OF THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153466 EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9610TF23U 63146695

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention