BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 6110874 · Received November 17, 2016

    Report

    Report Number
    2015691-2016-03400
    Event Type
    Death
    Date Received
    November 17, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 25, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS ONGOING.

    Additional Manufacturer Narrative · 1

    (B)(4). AN IMAGE REVIEW WAS PERFORMED. THE IMAGING SHOWED A SURGICAL BIOPROSTHETIC MITRAL VALVE IN PLACE AT THE START OF THE PROCEDURE. THE WIRE IS SEEN IN THE LEFT VENTRICLE VIA TRANSAPICAL APPROACH. UNABLE TO CONFIRM WIRE POSITION DUE TO ONLY 1 PROJECTION PROVIDED. NO IMAGES RELATED TO THE INTRODUCER SHEATH, BALLOON, DELIVERY SYSTEM, CRIMPED VALVE OR VALVE DEPLOYMENT WERE PROVIDED. THE VALVE IS SEEN FULLY DEPLOYED IN THE AORTIC POSITION. THE SAPIEN XT VALVE IS SEEN BEING REMOVED FROM THE AORTIC POSITION WITH FORCEPS AND PULLED THROUGH THE LEFT VENTRICLE APEX. THE LAST CINE IMAGE SHOWS A PIG TAIL CATHETER IN THE LEFT VENTRICLE FROM A TRANSFEMORAL ACCESS, CONTRAST INJECTION SHOWS A COMMUNICATION (APPEARS TO BE A LARGE VSD) FROM LV TO RV. NO IMAGE WAS PROVIDED OF A VSD IN THE PATIENT PRIOR TO IMPLANT. THE PROCEDURAL ECHO WAS OF POOR QUALITY. NO IMAGES WERE SEEN OF THE WIRE ACROSS THE VALVE. POST VALVE IMPLANT, A PAPILLARY MUSCLE IS SEEN MOVING (APPEARS TORN). PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DAMAGE (DISSECTION) OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. VENTRICULAR SEPTAL DEFECT (VSD) IS AN INFREQUENT BUT KNOWN POTENTIAL COMPLICATION OF THE TAVR PROCEDURE AND CAN OCCUR WITH BAV OR VALVE DEPLOYMENT. A SMALL VSD MAY NOT REQUIRE TREATMENT AND MAY BE TREATED CONSERVATIVELY. A LARGER VSD CAN CAUSE HEMODYNAMIC INSTABILITY AND WILL REQUIRE SURGICAL INTERVENTION. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN XT 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. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICE AT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR TO THE PLACEMENT AND FIXATION OF THE DEVICE. OPERATORS ARE ALSO INSTRUCTED TO USE FLUOROSCOPY AS THE PRIMARY METHOD OF VISUALIZATION FOR POSITIONING AND DEPLOYMENT. ADDITIONALLY, CARDIOVASCULAR COMPLICATIONS, INCLUDING PERFORATION OR DISSECTION OF VESSELS WHICH MAY REQUIRE INTERVENTION, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. THE THV TRAINING MANUALS NOTE THAT THAT REMOVAL OF THE SHEATH AND ATTEMPTED CLOSURE OF THE APICAL INCISION MAY BE ASSOCIATED WITH BLOOD LOSS. RAPID BURST PACING CAN BE USED TO LOWER THE SYSTEMIC BLOOD PRESSURE DURING SHEATH REMOVAL AND APICAL CLOSURE. THE THV TRAINING MANUALS ALSO RECOMMEND THE PHYSICIAN CONSIDER PERFORMING THE PROCEDURE UNDER FULL CPB SUPPORT FOR CERTAIN PATIENTS, INCLUDING THOSE WITH CARDIOGENIC SHOCK (CARDIAC INDEX < 2 L/MIN PER SQUARE METER) DESPITE VOLUME CHALLENGE AND INOTROPIC SUPPORT, PROFOUND LV, RV, OR BIVENTRICULAR DYSFUNCTION, AND NOTABLY FRIABLE APEX. IN THIS CASE THE INCORRECT PLACEMENT OF THE VALVE IN THE AORTIC POSITION INSTEAD OF THE INTENDED MITRAL POSITION WAS LIKELY CAUSED BY THE ALTERED POSITION OF THE PATIENT ON THE OR TABLE (WEDGE UNDER LEFT CHEST), MISCOMMUNICATION IN THE OR BETWEEN THE PHYSICIANS AND ECHOCARDIOLOGIST AND NOT CONFIRMING THE CORRECT POSITION OF THE WIRE AND VALVE WITH 3D ECHO AND FLUOROSCOPY IN MORE THAN ONE VIEW BEFORE DEPLOYMENT (USE ERROR). THE CAUSE OF THE TORN PAPILLARY MUSCLE AND VENTRICULAR SEPTAL DEFECT IS UNCLEAR BUT COULD BE RELATED TO THE REMOVAL OF THE DEPLOYED VALVE THROUGH THE APICAL ACCESS SITE WITH THE USE OF FORCEPS. IT IS BELIEVED THAT THEY ARE RELATED TO ONE ANOTHER. THE BLOOD LOSS WAS LIKELY THROUGH THE APICAL ACCESS SITE AND RELATED TO CPR AND CARDIAC MASSAGE PERFORMED. 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. THERE IS NO ALLEGATION OR INDICATION OF A DEVICE MALFUNCTION. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS AUSTRALIAN AFFILIATE, A 29 MM SAPIEN XT VALVE WAS PLANNED TO BE PLACED INSIDE A SURGICAL VALVE (VALVE IN VALVE) IN THE MITRAL POSITION. THE PATIENT WAS POSITIONED WITH WEDGES UNDER HIS LEFT SHOULDER WHICH CHANGED THE PREDETERMINED DEPLOYMENT ANGLE THAT WAS WORKED OUT BY THE PRE-PROCEDURAL CT. THE POSITIONING WAS NOT WELL SUPERVISED. IT WAS NOTED THAT THE VALVE WAS VERY EASY TO CROSS AND IT LOOKED AT THAT POINT THAT THE PERIMOUNT HAD BEEN CROSSED. ¿THE ECHOCARDIOLOGIST WAS ASKED IF HE COULD SEE THE WIRE THROUGH THE VALVE. IT WAS THOUGHT THE ANSWER HAD BEEN YES BUT HE ACTUALLY SAID HE COULDN'T SEE IT OR HE WASN¿T SURE IF HE COULD SEE IT. COMMUNICATION WAS IMPEDED BY THE NOISE IN THE ROOM. THE ANGLE OF THE C-ARM WAS NOT MOVED TO SEE THE WIRE IN THE VALVE IN ANOTHER PLANE.¿ THE VALVE WAS POSITIONED ACROSS THE PERIMOUNT VALVE AND THE BALLOON INFLATED. AFTER DEFLATING THE BALLOON, THE SAPIEN XT COULD BE SEEN MOVING INDEPENDENTLY OF THE PERIMOUNT VALVE. THE THV VALVE HAD BEEN DEPLOYED IN THE AORTIC VALVE. CARDIAC OUTPUT STOPPED IMMEDIATELY BECAUSE THE VALVE HAD BEEN PREPPED AND CRIMPED FOR MITRAL POSITION BUT MISTAKENLY DEPLOYED IN THE AORTIC POSITION, OCCLUDING BLOOD FLOW. THE PATIENT WAS PUT ON BYPASS AND IT WAS REALIZED THEY HAD A BLEED OF UNDETERMINED LOCATION, RESULTING IN AN ESTIMATED BLOOD LOSS OF 3000ML. AFTER EXTENSIVE DISCUSSION, IT WAS DETERMINED TO TERMINATE THE BYPASS SUPPORT AND PATIENT WAS PRONOUNCED DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759340 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX29

    Patients

    Seq Age Sex Outcome Treatment
    1 Death