BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3973826 · Received August 1, 2014

    Report

    Report Number
    2015691-2014-01768
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE SEVERAL POTENTIAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO A REPORT OF A RESTRICTED OR NON-FUNCTIONING LEAFLET. BASED ON HISTORICAL REVIEW OF COMPLAINTS, THESE EVENTS ARE TYPICALLY A RESULT OF TOO VENTRICULAR DEPLOYMENT OF THE VALVE IN COMBINATION WITH NATIVE LEAFLET OVERHANG. OTHER POTENTIAL CONTRIBUTING FACTORS INCLUDE: LEAFLET IMPINGEMENT IN A HIGHLY CALCIFIED NATIVE VALVE, IMPINGEMENT OF A LEAFLET DUE TO THE GUIDE WIRE, OR SLOW RECOVERY OF ADEQUATE VENTRICULAR FLOW POST VALVE DEPLOYMENT AND RAPID PACING. THIS CAN RESULT IN A TEMPORARY DECREASE IN THE PRESSURE GRADIENT BETWEEN THE VENTRICLE AND THE AORTA, RESULTING IN AN INADEQUATE PRESSURE CHANGE TO CLOSE THE LEAFLETS. IN MANY INSTANCES THIS CAN BE OVERCOME WITH TROUBLE SHOOTING, WHICH INCLUDES BLOOD PRESSURE RECOVERY OR SUPPORT. OCCASIONALLY THERE ARE CASES WHERE THE ROOT CAUSE OF THE NON-FUNCTIONING LEAFLET CANNOT BE DETERMINED. PER THE INSTRUCTIONS FOR USE (IFU), DEVICE EMBOLIZATION AND CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DAMAGE (DISSECTION) OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE TAVR PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VENTRICULAR EMBOLIZATION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, A NARROW, CALCIFIED SINOTUBULAR JUNCTION, MINIMALLY CALCIFIED AORTIC LEAFLETS, AND LOSS OF PACING CAPTURE. 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. 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. IN PATIENTS WITH HIGH-RISK ANATOMICAL FEATURES FOR VENTRICULAR EMBOLIZATION (I.E. SMALL, CALCIFIED STJ, MINIMAL LEAFLET CALCIFICATION), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT DURING THE MANUFACTURING PROCESS, ALL EDWARDS VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR COAPTATION PRIOR TO RELEASE FOR DISTRIBUTION. THIS MAKES IT HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION WOULD CONTRIBUTE TO THE EVENT. IN THIS CASE, THE INITIAL CAUSE OF THE RESTRICTED LEAFLET MOTION IS A RESULT OF SLOW BLOOD PRESSURE RECOVERY FROM THE PATIENT. THE MOVEMENT OF THE PIGTAIL AFTER THE SECOND VALVE DEPLOYMENT CAUSED THE VALVE TO EMBOLIZE. THE EXACT CAUSE OF THE AORTIC DISSECTION CANNOT BE DETERMINED. IT IS POSSIBLE THAT ADVANCED AGE COMBINED WITH THE VALVE IN VALVE PROCEDURE MAY HAVE CONTRIBUTED TO THIS 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2014-01764.

    Description of Event or Problem · 1

    DURING THE TRANSAPICAL TAVR PROCEDURE, A 23MM SAPIEN VALVE WAS DEPLOYED WITH A FINAL POSITION OF 60:40 AORTIC/VENTRICULAR, RESULTING IN NO PARAVALVULAR LEAK (PVL) AND ¿WIDE OPEN¿ CENTRAL AORTIC INSUFFICIENCY (CAI). IT WAS DETERMINED THAT ONE LEAFLET WAS NOT MOVING. THE GUIDEWIRE WAS REMOVED AND UNSUCCESSFUL ATTEMPTS WERE MADE TO FREE THE LEAFLET WITH THE PIGTAIL. VASOPRESSORS WERE ALSO GIVEN. THE PATIENT WAS DETERIORATING SO THE DECISION WAS MADE TO PLACE A SECOND VALVE. THE VALVE WAS DEPLOYED 50:50 AND NO PVL OR CAI WAS NOTED. AFTER ASSESSMENT OF THE VALVE, THE PIGTAIL WAS PULLED BACK. THIS MOVEMENT CAUSED THE SECOND VALVE TO EMBOLIZE OUT OF THE FIRST VALVE AND WEDGE IN THE LVOT. THE VALVE APPEARED TO BE LODGED TIGHTLY. ECHO INDICATED THAT THE FIRST VALVE, POSITIONED 60:40 A/V, WAS NOW FUNCTIONING PERFECTLY, AND THE SECOND VALVE WAS ALSO FUNCTIONING WELL. THE DECISION WAS MADE TO LEAVE BOTH VALVES IMPLANTED, AND THE INCISION WAS CLOSED. APPROXIMATELY 10 MINUTES AFTER CLOSURE, THE PATIENT DETERIORATED WITH HEART RATES IN THE 30¿S. THE PATIENT WAS CONVERTED TO OPEN SURGERY. BOTH SAPIEN VALVES WERE REMOVED AND A SURGICAL VALVE WAS IMPLANTED. DURING THE OPEN SURGERY A SMALL TEAR IN THE ROOT, BEHIND THE FIRST VALVE, WAS FOUND AND PATCHED. THE PROCEDURE WAS COMPLETED AND AN IABP WAS INSERTED. THE PATIENT WAS TAKEN TO ICU. AT THE TIME OF THIS REPORT, THE PATIENT WAS RESPONDING TO STIMULUS, BUT STILL IN CRITICAL CONDITION. THE CAUSE OF THE VALVE LEAFLET NOT WORKING WAS LIKELY RELATED TO THE PATIENT¿S LOW BLOOD PRESSURE POST DEPLOYMENT. THE PATIENT¿S NATIVE ANNULUS AREA MEASURED 360MM2 BY CT. THERE WAS SEVERE NATIVE VALVE CALCIFICATION AND MILD ROOT CALCIFICATION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450304 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention