BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2960141 · Received February 13, 2013

    Report

    Report Number
    2015691-2013-19272
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 15, 2013
    Report Date
    March 1, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S MEDICAL RECORDS WERE FORWARDED FROM THE HOSPITAL. ACCORDING TO THE MEDICAL RECORDS, AT THE TIME OF THE INITIAL TAVR PROCEDURE, POST DEPLOYMENT OF THE FIRST SAPIEN VALVE, THE VALVE WAS PLACED TOO AORTIC RESULTING IN 2 TO 3+ PVL. A SECOND VALVE WAS PLACED WITH A FINAL RESULT OF ZERO PVL. THE PATIENT ALSO EXPERIENCED INTRA-OPERATIVE CARDIAC ARREST AND CPR WAS PERFORMED FOR 6 MINUTES. THIS EVENT WAS REPORTED UNDER FDA REPORT #2015691-2013-19023 (INITIAL AND FOLLOW UP #1). THE DAY AFTER IMPLANTATION, THE PATIENT REQUIRED A PERMANENT PACEMAKER INSERTION FOR COMPLETE HEART BLOCK. REFER TO FDA REPORT #2015691-2013-19516. SHE HAD MANY EPISODES OF ATRIAL FIBRILLATION AS WELL. HER HOSPITALIZATION WAS COMPLICATED WITH MULTIPLE EVENTS, INCLUDING URINARY TRACT INFECTION, MULTIPLE EPISODES OF PLEURAL EFFUSION, ANOREXIA, EXTREME LETHARGY WITH CO2 RETENTION AND RE-INTUBATION. THE PATIENT HAD A POSTOPERATIVE ECHOCARDIOGRAM WHICH SHOWED SEVERE AI, FOLLOWED BY TEE, WHICH SHOWED OPEN AI AND SEVERE MR. AS A RESULT OF THE FINDINGS, THE PLAN WAS TO HAVE THE PATIENT UNDERGO AN AORTIC VALVE REPLACEMENT PROCEDURE. AT 35 DAYS S/P TAVR THE PATIENT HAD EXPLANTATION OF THE TWO SAPIEN VALVES. THE SAPIEN VALVE WAS CAREFULLY EXAMINED AFTER THE AORTA WAS OPENED. BOTH VALVES WERE IN THEIR APPROPRIATE POSITIONS. THE SECOND VALVE LEAFLETS WERE NOT COAPTING. 'IT LOOKED LIKE WHEN THE VALVE WAS PUT IN, IT WAS FAIRLY TIGHT WHICH DEFORMED THE WHOLE NITINOL WHICH SUPPORTS THE VALVE AND MADE THE VALVE INCOMPETENT.' AFTER COMPLETION OF THE PROCEDURE, THE NEW VALVE WAS FOUND TO BE OPENING AND CLOSING WELL WITH TRACE PVL. THE SURGICAL PROCEDURE WAS SUCCESSFUL. PER THE DEVICE'S INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES INCLUDE BUT ARE NOT LIMITED TO CENTRAL LEAK. 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 PHYSICIANS UNDERGO EXTENSIVE TRAINING BY EDWARDS LIFESCIENCES IN ORDER TO PERFORM THV PROCEDURES. TRAINING INCLUDES DEVICE PREPARATION, APPROACH, POSITIONING AND DEPLOYMENT, IMAGING, TRAINING MANUALS AND PROCTORED PROCEDURES. THE PHYSICIANS' TRAINING MANUALS INSTRUCT THE PHYSICIAN ON THE PROPER STEPS AND TECHNIQUES FOR SUCCESSFUL VALVE DEPLOYMENT. THE PHYSICIANS ARE ALSO TRAINED TO CONSIDER PATIENT FACTORS SUCH AS, SIGNIFICANT VALVE OVER-SIZING (= 4 MM), SEVERE SEPTAL HYPERTROPHY, MINIMAL VALVE/LEAFLET CALCIFICATION, AND PRESERVED EJECTION FRACTION (EF). TECHNICAL CONSIDERATIONS INCLUDE SUB-OPTIMAL IMAGE INTENSIFIER (I/I) ANGLE, NON-COAXIAL ALIGNMENT OF THE GUIDEWIRE/ VALVE/ DELIVERY SYSTEM, IMPROPER VALVE POSITION PRE-DEPLOYMENT, BALLOON INFLATION = 3 SEC DURING DEPLOYMENT, OR LOSS OF PACING CAPTURE DURING DEPLOYMENT. THIS PATIENT HAS SEVERE CALCIFICATION OF THE NATIVE VALVE AND LEAFLETS AND SEVERE MITRAL ANNULAR CALCIFICATION (MAC) AND TWO 23MM SAPIEN VALVES WERE PLACED WITHIN AN ANNULUS MEASURING 20MM. IN THIS PARTICULAR CASE, THE CAUSE OF THE REPORTED POST PROCEDURAL NON-FUNCTIONING LEAFLETS CAUSING CENTRAL REGURGITATION AS MENTIONED IN THE MEDICAL RECORDS APPEARS TO BE DUE TO FAIRLY TIGHT FIT WHICH DEFORMED THE WHOLE FRAME WHICH SUPPORTS THE VALVE AND MADE THE SECOND VALVE INCOMPETENT. THE 'TIGHT FIT' DESCRIBED IN THE MEDICAL RECORDS MAY HAVE RESULTED FROM A COMBINATION OF THE SEVERE CALCIFICATION OF THE NATIVE LEAFLETS AND THE FIRST SAPIEN VALVE TAKING UP SPACE IN THE AVAILABLE AREA OF DEPLOYMENT FOR THE SECOND SAPIEN VALVE, AND NOT ALLOWING THE LEAFLETS TO FULLY EXPAND. THE IFU AND EDWARDS THV PATIENT SCREENING 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. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS 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 PREVENTIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY WAS NOTIFIED THAT 35 DAYS S/P TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE THE EDWARDS SAPIEN VALVE WAS EXPLANTED DUE TO AORTIC INSUFFICIENCY. THE VALVE WAS REPLACED WITH A SURGICAL VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62389 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23 3065790

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention