BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2882023 · Received December 20, 2012

    Report

    Report Number
    2015691-2012-18908
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTIONS FOR USE, DEVICE MALPOSITION REQUIRING INTERVENTION AND VALVE REGURGITATION ARE KNOWN POTENTIAL ADVERSE EVENTS 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 AORTIC MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, 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 AND ANATOMICAL 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. PER REPORT, RAPID INFLATION, TENSION IN THE SYSTEM AND LVOT CALCIUM CONTACTING THE DELIVERY BALLOON ALL CONTRIBUTED TO THE AORTIC MOVEMENT OF THE VALVE. IT IS ALSO POSSIBLE THAT THE FAIR COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM (LIKELY THE CAUSE OF TENSION IN THE SYSTEM) AND THE PATIENT'S PRESERVED EJECTION FRACTION CONTRIBUTED TO THE EVENT. THE FINAL 90:10 AORTIC POSITION OF THE VALVE, IN COMBINATION WITH SEVERE NATIVE VALVE CALCIFICATION, LIKELY RESULTED IN THE REPORTED SEVERE PVL. 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.

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE THE VALVE MOVED AORTIC DURING DEPLOYMENT TO A 90:10 POSITION. THIS RESULTED IN SEVERE PARAVALVULAR LEAK (PVL) REQUIRING A SECOND VALVE. ADDITIONAL INFORMATION REVEALED THE FOLLOWING: THE AORTIC ROOT WAS MODERATELY CALCIFIED AND THE NATIVE LEAFLETS WERE SEVERELY CALCIFIED. THE PATIENT'S LEFT VENTRICULAR EJECTION FRACTION WAS 70%. A 23MM VALVE WAS POSITIONED 50:50 AS CONFIRMED BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND ANGIO. THE VALVE WAS INFLATED AND DURING INFLATION MOVED AORTIC CONSIDERABLY. SEVERE PVL WAS NOTED; HOWEVER THE VALVE SEEMED STABLE. A SECOND 23MM VALVE WAS PREPPED AND POSITIONED 50:50 ON THE INFLOW OF THE FIRST VALVE. THE VALVE WAS INFLATED SLOWLY AND DURING MAXIMAL INFLATION THE DELIVERY BALLOON BURST. THE VALVE WAS POST-DILATED WITH A ZMED BALLOON AND FINAL PVL WAS MILD. THE IMAGE INTENSIFIER ANGLE WAS DESCRIBED AS GOOD, AND THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WAS DESCRIBED AS FAIR. DURING SAPIEN VALVE DEPLOYMENT, VENTILATION WAS HELD, BALLOON INFLATION WAS HELD FOR THREE OR MORE SECONDS, AND PACING CAPTURE WAS NOT LOST. PER REPORT, THE THOUGHT IS THAT RAPID INFLATION, TENSION IN THE SYSTEM AND LVOT CALCIUM CONTACTING THE DELIVERY BALLOON ALL CONTRIBUTED TO THE AO MOVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention