BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3120339 · Received May 20, 2013

    Report

    Report Number
    2015691-2013-20120
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 24, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), DEVICE MALPOSITION REQUIRING INTERVENTION AND PARAVALVULAR LEAK ARE KNOWN POTENTIAL COMPLICATIONS 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 DURING IMPLANTATION, 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. 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. POST PROCEDURE AND LATE VENTRICULAR ARRHYTHMIAS CAN BE ASSOCIATED WITH PATIENT FACTORS SUCH AS POOR VENTRICULAR FUNCTION, INADEQUATE CORONARY PERFUSION, TAMPONADE, HYPOVOLEMIA OR ELECTROLYTE DEFICIENCIES (E.G. HYPOKALEMIA, HYPOCALCEMIA, HYPOMAGNESEMIA). VENTRICULAR ARRHYTHMIAS CAN ALSO BE ASSOCIATED WITH SIGNIFICANT POST PROCEDURAL BLEEDING FROM THE TA ACCESS SITE. THIS PATIENT POPULATION IS TYPICALLY ELDERLY, MAY BE NON-OPERATIVE OR HIGH RISK, HAVE COMPLEX MEDICAL HISTORIES, MULTIPLE CO-MORBIDITIES, AND LOWER CARDIAC RESERVE THAT CAN LIMIT THEIR ABILITY TO RECOVER FROM THE MEDICAL CONDITIONS ABOVE. IN THE ABSENCE OF VALVE DYSFUNCTION OR VALVE RELATED ISCHEMIA, POST-PROCEDURE AND LATE VENTRICULAR ARRHYTHMIAS ARE HIGHLY UNLIKELY TO BE RELATED TO THE IMPLANTED VALVE. IN THIS CASE, THE CAUSE OF THE REPORTED CARDIAC ARREST AND PVL NOTICED POST TAVR CANNOT BE CONFIRMED; HOWEVER, THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. PER THE OP REPORT, THE PATIENT HAS A COMPLEX MEDICAL HISTORY, INCLUDING SERIOUS CARDIAC CONDITIONS (E.G. PROGRESSIVE DETERIORATION OF LV FUNCTION, EF OF 20%) WHICH IN COMBINATION WITH THE PROCEDURE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED BRADYCARDIA AND CARDIAC ARREST REQUIRING CPR 24 HRS POST TAVR. THE REPORTED INCREASED AORTIC REGURGITATION (BOTH CENTRAL AND PERIVALVULAR LEAKS) WAS NOTICED AFTER THE PATIENT HAD RECEIVED CPR ON 2 OCCASIONS. AT THE TIME OF EXPLANT, THE SURGEON FOUND THE VALVE IN A TOO VENTRICULAR POSITION BUT IT WAS NOT CLEAR IF THIS WAS THE POSITION POST DEPLOYMENT OR IF THE VALVE HAD MOVED TO THIS POSITION DURING CPR. BECAUSE THE PROCEDURE WAS CONSIDERED SUCCESSFUL AND THE DEGREE OF REGURGITATION BECAME SIGNIFICANT AFTER CPR, IT SEEMS REASONABLY LIKELY THAT THE VALVE MOVED DURING CPR. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. 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

    INVESTIGATION OF THIS EVENT IS ONGOING.

    Description of Event or Problem · 1

    EDWARDS WAS NOTIFIED THROUGH THE THV IMPLANT REGISTRY THAT THE 23MM SAPIEN VALVE WAS REMOVED 2 DAYS AFTER IMPLANT AND WAS REPLACED WITH A 23MM EDWARDS¿S SURGICAL VALVE. ACCORDING TO THE MEDICAL RECORDS PROVIDED BY THE FACILITY THE TAVR PROCEDURE HAD BEEN SUCCESSFUL. POST DEPLOYMENT THE SAPIEN VALVE WAS FOUND TO HAVE MILD CENTRAL LEAK AND TRACE PARAVALVULAR LEAK ON THE TEE AND ANGIO IMAGES. IT WAS REPORTED THAT POST PROCEDURE THE VALVE WAS FOUND TO HAVE MODERATE PVL, WHICH SHE SEEMED TO TOLERATE WELL. HOWEVER, 24 HOURS LATER THE PATIENT BECAME BRADYCARDIC, REQUIRED A TEMPORARY PACEMAKER AND HAD A CARDIAC ARREST. THE PATIENT WAS GIVEN CPR ON 2 DIFFERENT OCCASIONS. THE AMOUNT OF AORTIC REGURGITATION INCREASED; NOW IT APPEARED TO HAVE BOTH SEVERE CENTRAL AND PERIVALVULAR LEAKS. THE PATIENT WAS RE-INTUBATED AND PLACED IN IABP. IN ADDITION, SHE DEVELOPED RENAL FAILURE AND WAS PLACED ON CVVH. THE PATIENT WAS TAKEN TO THE OR TO REDO THE AORTIC VALVE REPLACEMENT AS A SALVAGE PROCEDURE. PER THE OPERATIVE FINDINGS THE PATIENT HAD SEVERE AORTIC REGURGITATION. IT APPEARED THAT THE SAPIEN VALVE WAS PLACED TOO LOW. IT COULD NOT BE EXCLUDED THAT IT WAS DISLODGED IN THIS POSITION DUE CPR. AT THE END OF THE AVR PROCEDURE THE PATIENT HAD A WELL-FUNCTIONING VALVE WITH NO PVL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222283 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention