BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3021312 · Received March 26, 2013

    Report

    Report Number
    2015691-2013-19653
    Event Type
    Death
    Date Received
    March 26, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE AND THE PATIENT SCREENING MANUAL, VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE EDWARDS SAPIEN RETROFLEX 3 TRANSFEMORAL DELIVERY SYSTEM TRAINING GUIDE INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. FACTORS THAT CAN CONTRIBUTE TO IMPAIRED LEAFLET COAPTATION INCLUDE OVER INFLATION OF THE DEPLOYMENT BALLOON AND NATIVE LEAFLET OVERHANG. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER NATIVE VALVE LEAFLET ASSESSMENT, TAKING INTO CONSIDERATION THE LENGTH, BULKINESS AND DISTRIBUTION OF CALCIUM ON THE NATIVE LEAFLETS TO DETERMINE WHETHER SAPIEN VALVE PERFORMANCE WILL BE IMPAIRED. IN ADDITION, HYPOTENSION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY (BAV), THE USE OF ANESTHESIA, AORTIC VALVE REPLACEMENT AND THE TAVR PROCEDURE. HYPOTENSION IS EXTREMELY COMMON DURING THE TRANSAORTIC VALVE IMPLANT PROCEDURE AND HAS MULTIPLE POTENTIAL ETIOLOGIES, INCLUDING THE EFFECTS OF ANESTHESIA AND RAPID VENTRICULAR PACING, AND IS REQUIRED DURING BAV AND SUBSEQUENT VALVE DEPLOYMENT. IN THIS CASE, THE ROOT CAUSE OF THE REPORTED INITIAL NON-FUNCTIONING LEAFLET CANNOT BE CONFIRMED; HOWEVER, IT IS POSSIBLE THAT PATIENT'S BLOOD PRESSURE WAS SLOW TO RECOVER FOLLOWING RAPID VENTRICULAR PACING, WHICH MAY HAVE LED TO A DELAY IN OBTAINING AN ADEQUATE PRESSURE TO MOBILIZE THE LEAFLET. ALTHOUGH THE ROOT CAUSE OF THE REPORTED INTRAOPERATIVE HYPOTENSION ALSO CANNOT BE CONFIRMED, THE PATIENT'S DECREASED EJECTION FRACTION (10%) IN COMBINATION WITH ANESTHESIA, PROCEDURAL MEDICATIONS, AND RVP DURING VALVE DEPLOYMENT LIKELY CONTRIBUTED TO THE EVENT. OF NOTE, THE TAVR PROCEDURE IS CONTRAINDICATED FOR PATIENTS WITH EJECTION FRACTIONS UNDER 20%. 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, AFTER DEPLOYMENT OF THE SAPIEN VALVE THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE, REQUIRED CPR AND WAS PLACED ON CARDIOPULMONARY BYPASS (CPB) DUE TO A LOW EJECTION FRACTION (EF) AND LOW BLOOD PRESSURE. THE PHYSICIANS FELT THAT ONE OF THE LEAFLETS OF THE SAPIEN VALVE WAS NOT MOVING. A SECOND VALVE WAS DEPLOYED INSIDE FIRST SAPIEN VALVE AND FUNCTIONED WELL. WHILE ATTEMPTING TO CLOSE THE APEX THE PHYSICIANS NOTICED A GREAT AMOUNT OF BLEEDING AND WERE FORCED TO OPEN THE PATIENT UP TO REPAIR A PERFORATED RIGHT ATRIUM. THE PATIENT WAS STABILIZED, TAKEN OFF OF CPB, AND LEFT THE OPERATING ROOM IN STABLE CONDITION. HOWEVER, IT WAS REPORTED THAT THE PATIENT EXPIRED IN THE INTENSIVE CARE UNIT THE FOLLOWING DAY. THE NATIVE AORTIC ANNULAR DIAMETER WAS 21MM. THE PATIENT'S EJECTION FRACTION (EF) WAS 10%. THE SAPIEN VALVE WAS POSITIONED AND DEPLOYED IN A 50:50 POSITION ACROSS THE MODERATELY CALCIFIED NATIVE AORTIC ANNULUS. THE IMAGE INTENSIFIER ANGLE AND THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WERE BOTH DESCRIBED AS GOOD. PER REPORT, THE PERFORATION OF THE RIGHT ATRIUM WAS DUE TO WIRE ADVANCEMENT FROM THE TEMPORARY PACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123267 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death