BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3040864 · Received April 8, 2013

    Report

    Report Number
    2015691-2013-19757
    Event Type
    Death
    Date Received
    April 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED FOR EVALUATION AS IT WAS CRUSHED WHEN THE EMBOLIZED VALVE WAS MANUALLY RETRIEVED FROM THE LEFT VENTRICLE OF THE PATIENT. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOGENIC SHOCK AND VALVE EMBOLIZATION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE SEVERAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VENTRICULAR MALPOSITION AND/OR EMBOLIZATION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, A NARROW, CALCIFIED SINOTUBULAR JUNCTION, MINIMAL VALVE CALCIFICATION, AND LOSS OF PACING CAPTURE. THE PROCEDURAL DIDACTIC INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING INCLUDES 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. CARDIOGENIC SHOCK CAN HAVE MULTIPLE ETIOLOGIES, INCLUDING MYOCARDIAL INFARCTION, VENTRICULAR TACHYCARDIA, CARDIOMYOPATHY, AND DAMAGE TO THE HEART MUSCLE. IT IS MOST OFTEN DUE TO POOR VENTRICULAR FUNCTION. OTHER MAJOR RISK FACTORS THAT MAY PREDISPOSE A PATIENT TO CARDIOGENIC SHOCK INCLUDE ADVANCED AGE, A HISTORY OF HEART FAILURE, PREVIOUS MYOCARDIAL INFARCTION, AND CORONARY ARTERY DISEASE. THE CAUSE OF THE REPORTED CARDIOVASCULAR COLLAPSE POST VALVE DEPLOYMENT CANNOT BE CONFIRMED; HOWEVER, IN ADDITION TO PROCEDURAL MEDICATIONS, ANESTHESIA AND RAPID VENTRICULAR PACING DURING VALVE DEPLOYMENT, THE PATIENT'S ADVANCED AGE AND DECREASED EF (40%) MAY HAVE ALSO CONTRIBUTED TO THE EVENT. OF NOTE, THE PATIENT WAS PREPPED FOR CPB PRIOR TO THE TAVR PROCEDURE DUE TO A HIGH RISK OF HEMODYNAMIC DECOMPENSATION. THE CAUSE OF THE VENTRICULAR IMPLANTATION OF THE SECOND SAPIEN VALVE CANNOT BE CONFIRMED; HOWEVER, ONLY MODERATE NATIVE VALVE AND MILD ROOT CALCIFICATION IN COMBINATION WITH MODERATE SINOTUBULAR JUNCTION (STJ) CALCIFICATION HAVE CONTRIBUTED TO THE VENTRICULAR SHIFT UPON DEPLOYMENT AND THE SUCCESSIVE MIGRATION. PER REPORT, THE PHYSICIANS FELT THAT THE CHEST COMPRESSIONS DURING CPR MAY HAVE CONTRIBUTED TO THE DISLODGEMENT AND SUBSEQUENT EMBOLIZATION OF THE SAPIEN VALVE. 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 AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, A 26MM SAPIEN VALVE WAS SUCCESSFULLY IMPLANTED 50:50 ACROSS THE NATIVE AORTIC ANNULUS VIA A TRANSAPICAL APPROACH, RESULTING IN NO PARAVALVULAR LEAK AND TRACE CENTRAL AORTIC INSUFFICIENCY. AS THE PATIENT WAS BEING TRANSFERRED TO THE RECOVERY ROOM SHE DEVELOPED HYPOTENSION AND BRADYCARDIA, WHICH PROGRESSED TO VENTRICULAR FIBRILLATION (VF). THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM AND CHEST COMPRESSIONS WERE INITIATED. THE PATIENT WAS DEFIBRILLATED MULTIPLE TIMES FOR SUSTAINED VF. THE TEE PROBE WAS REINSERTED TO ASSESS THE POSITION OF THE SAPIEN VALVE, AND IT APPEARED THAT THE VALVE HAD PARTIALLY MIGRATED INTO THE LEFT VENTRICLE OUTFLOW TRACK (LVOT). UPON CONTINUED OBSERVATION WITH TEE, THE SAPIEN VALVE CONTINUED TO MIGRATE AND EMBOLIZED INTO THE LEFT VENTRICLE. THE PATIENT WAS HEMODYNAMICALLY STABLE AT THIS POINT. THE PHYSICIANS DECIDED TO REOPEN THE VENTRICULOTOMY SITE AND DEPLOY ANOTHER 26MM SAPIEN VALVE. THE SECOND 26MM VALVE WAS PREPPED AND DEPLOYED 50:50 IN THE NATIVE ANNULUS BUT SHIFTED VENTRICULAR DURING DEPLOYMENT. A THIRD 26MM SAPIEN VALVE WAS THEN SUCCESSFULLY IMPLANTED 50:50 AORTIC WITHIN THE SECOND SAPIEN VALVE. ANGIO AND TEE IMAGING CONFIRMED ADEQUATE POSITION OF THE THIRD VALVE WITHIN THE ANNULUS. THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS (CPB) WHILE THE PHYSICIAN MANUALLY RETRIEVED THE EMBOLIZED VALVE FROM THE LV THROUGH THE VENTRICULOTOMY. THE VENTRICULOTOMY SITE WAS CLOSED, AND ATTEMPTS WERE MADE TO REMOVE THE PATIENT FROM CPB WITHOUT SUCCESS. THE DECISION WAS MADE TO STOP RESUSCITATION EFFORTS AND THE PATIENT ULTIMATELY EXPIRED ON THE TABLE. THE NATIVE AORTIC ANNULAR DIAMETER WAS 22MM BY TEE. THE NATIVE AORTIC VALVE WAS MODERATELY CALCIFIED, THE NATIVE AORTIC ROOT WAS MILDLY CALCIFIED, AND THE SINOTUBULAR JUNCTION (STJ) WAS MODERATELY CALCIFIED. THE PATIENT'S EJECTION FRACTION (EF) WAS 40%. BOTH IMAGE INTENSIFIER ANGLE (IIA) AND THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WERE DESCRIBED AS GOOD. THE PATIENT WAS PREPPED FOR CPB PRIOR TO THE TAVR PROCEDURE DUE TO A HIGH RISK OF HEMODYNAMIC DECOMPENSATION. PER REPORT, THE PHYSICIANS FELT THAT THE CHEST COMPRESSIONS DURING CPR MAY HAVE CONTRIBUTED TO THE DISLODGEMENT AND SUBSEQUENT EMBOLIZATION OF THE SAPIEN VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142692 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death