BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3882071 · Received June 18, 2014

    Report

    Report Number
    2015691-2014-01399
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: EVALUATION CODES, 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. 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 SAPIEN VALVE WAS FOUND TO BE LODGED AT AN ANGLE AND BELOW THE NATIVE LEAFLET ON THE NON-CORONARY SIDE, WITH THE SAPIEN VALVE LEAFLET IMPINGED IN AN OPEN POSITION. IT IS UNKNOWN WHAT CAUSED THE MALPOSITION, HOWEVER, CAI AND PVL RESULTED, AND THE SAPIEN VALVE WAS EXPLANTED. 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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    FOUR MONTHS POST TAVR, SEVERE CENTRAL AORTIC INSUFFICIENCY (CAI) AND SEVERE PARAVALVULAR LEAK (PVL) WAS NOTED. THE SAPIEN VALVE WAS EXPLANTED AND REPLACED WITH AN EDWARDS MAGNA VALVE. DURING THE INITIAL TAVR PROCEDURE, THE 26MM SAPIEN VALVE DEPLOYMENT WENT WELL. THERE WAS A PREMATURE VENTRICULAR CONTRACTION (PVC) AND ¿SOME ROCKING¿ AT ORIGINAL DEPLOYMENT. HOWEVER, POST DEPLOYMENT ECHO INDICATED GOOD POSITION WITH TRACE TO MILD CENTRAL AI, AND EXCELLENT VALVE FUNCTION WITH A MEAN GRADIENT OF 6MMHG. THE PATIENT WAS TRANSFERRED TO ICU IN STABLE CONDITION, AND DISCHARGED TO HOME POD2. FOUR MONTHS POST TAVR, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE, COMPLAINING OF CHEST WALL PAIN. THE PATIENT WAS SEEN IN CLINIC AND AN ECHO SHOWED MODERATE TO SEVERE PARAVALVULAR LEAK. A NEW TEE INDICATED MODERATE STENOSIS OF THE TRANSCATHETER VALVE, WITH SEVERE CENTRAL AORTIC INSUFFICIENCY OBSERVED AT THE NON-CORONARY CUSP AREA WITH A JET RUNNING ALONG THE ANTERIOR MITRAL VALVE LEAFLET. LEAFLET MOTION APPEARED SOMEWHAT LIMITED. THEREFORE OPEN SURGERY WAS PERFORMED. THE SAPIEN VALVE WAS FOUND TO BE LODGED AT AN ANGLE AND BELOW THE NATIVE LEAFLET ON THE NON-CORONARY SIDE WITH THE SAPIEN VALVE LEAFLET IMPINGED IN AN OPEN POSITION. THE NATIVE VALVE LEAFLETS AND SAPIEN VALVE WERE REPLACED WITH A 23MM EDWARDS MAGNA PROSTHETIC VALVE. THE PATIENT WAS REMOVED FROM BYPASS WITHOUT DIFFICULTY AND TAKEN TO ICU IN STABLE CONDITION THE PATIENT¿S NATIVE VALVE DIAMETER MEASURED 23X27.7MM (VALVE AREA OF 446.5MM2) BY CT WITH MILD NATIVE VALVE CALCIFICATION AND NO ROOT CALCIFICATION NOTED. THE COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND VALVE AND THE IMAGE INTENSIFIER ANGLE DURING THE TAVR PROCEDURE WERE BOTH REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359313 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention