BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 5816096 · Received July 22, 2016

    Report

    Report Number
    2015691-2016-02313
    Event Type
    Death
    Date Received
    July 22, 2016
    Date of Event
    May 18, 2016
    Report Date
    July 1, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE INSTRUCTIONS FOR USE (IFU), VALVE MALPOSITION REQUIRING INTERVENTION AND CENTRAL REGURGITATION ARE KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VENTRICULAR MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, A NARROW, CALCIFIED SINOTUBULAR JUNCTION, MINIMALLY OR BULKY/SEVERELY CALCIFIED AORTIC LEAFLETS, RAPID DEPLOYMENT, RELEASE OF STORED TENSION DURING DEPLOYMENT, AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. PER THE INSTRUCTIONS FOR USE, CENTRAL REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO CENTRAL REGURGITATION INCLUDING MALPOSITION OF THE VALVE, IMPINGEMENT OF A LEAFLET DUE TO THE GUIDE WIRE, OVER INFLATION OF THE DEPLOYMENT BALLOON, POST DILATION OF THE IMPLANTED VALVE, AND SLOW RECOVERY OF ADEQUATE VENTRICULAR FLOW POST VALVE DEPLOYMENT AND RAPID PACING. ALL OF THESE FACTORS HAVE THE POTENTIAL TO CONTRIBUTE TO SUBOPTIMAL COAPTATION OF THE SAPIEN VALVE LEAFLETS AND CAUSE CENTRAL AORTIC INSUFFICIENCY. OCCASIONALLY THERE ARE CASES WHERE THE ROOT CAUSE OF THE REGURGITATION CANNOT BE DETERMINED. DURING THE MANUFACTURING PROCESS, ALL SAPIEN 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. 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 MALPOSITION (I.E. SMALL, CALCIFIED STJ, MINIMAL LEAFLET CALCIFICATION), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. IN THIS CASE, THE PATIENT¿S HORIZONTAL AORTA IS A LIKELY CONTRIBUTING FACTOR FOR THE VENTRICULAR VALVE PLACEMENT. THE CAUSE FOR THE CENTRAL AI COULD NOT BE DETERMINED, HOWEVER, THE AMPLATZ WIRE ACROSS THE TAVR VALVE HOLDING A LEAFLET OPEN OR THE MALPOSITION OF THE VALVE MAY HAVE BEEN CONTRIBUTING FACTORS. THE CAUSE OF DEATH COULD NOT BE DETERMINED, HOWEVER, A CHANGE IN THE AORTIC VALVE AREA MAY HAVE BEEN A CONTRIBUTING FACTOR AS A PROSTHETIC MITRAL VALVE WAS IMPLANTED 2 WEEKS PRIOR. 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

    DURING A TAVR PROCEDURE, WHILE POSITIONING A 29MM SAPIEN 3 VALVE, THE PATIENT'S PRESSURE DROPPED. THE VALVE WAS DEPLOYED, BUT MOVED VENTRICULAR AND LANDED LOWER IN THE NON-CORONARY CUSP. AFTER VALVE DEPLOYMENT, THE PATIENT'S PRESSURE STAYED IN THE 60S. ECHO SHOWED NO EFFUSION. IT COULD NOT BE DETERMINE WHETHER THE FIRST VALVE WAS CRITICALLY LOW BY TEE OR IF THERE WAS PVL OR CAI AS THE PATIENT'S HEART NEVER RECOVERED. ANOTHER 29MM SAPIEN 3 VALVE WAS ATTEMPTED TO BE DEPLOYED IN A MORE AORTIC POSITION, HOWEVER, IT LANDED IN THE SAME SPOT AS THE FIRST VALVE. THE PATIENT DID NOT RECOVER POST VALVE DEPLOYMENT AND EXPIRED. THE EXACT CAUSE OF DEATH WAS UNKNOWN. NO AUTOPSY WILL BE PERFORMED. THE PATIENT HAD A VERY HORIZONTAL AORTA. AN ANNULAR RUPTURE WAS SUSPECTED, HOWEVER, NO EFFUSION OR DISSECTION WAS NOTED ON ECHO. THE PATIENT HAD A PROSTHETIC MITRAL VALVE IMPLANTED 2 WEEKS PRIOR. IT WAS SPECULATED THE MITRAL IMPLANT CAUSED THE AORTIC VALVE AREA TO DECREASE, HOWEVER, IT COULD NOT BE CONFIRMED AS A REPEAT CT WAS NOT PERFORMED POST MITRAL VALVE IMPLANT AND PRIOR TO THE TAVR PROCEDURE. ADDITIONAL RECORDS WERE RECEIVED. POST DEPLOYMENT OF THE FIRST VALVE, "THERE APPEARED TO BE A CENTRAL JET OF AI WITH THE AMPLATZ ES WIRE ACROSS THE TAVR VALVE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468848 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX29

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death