BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2983880 · Received February 28, 2013

    Report

    Report Number
    2015691-2013-19424
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT; HOWEVER, THERE IS NO ALLEGATION OF DEVICE MALFUNCTION. 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 OR 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. IN THIS CASE, THE ROOT CAUSE FOR THE AORTIC MALPOSITION CANNOT BE CONFIRMED; HOWEVER, THE AORTIC MALPOSITION IN COMBINATION WITH THE REPORTED SEVERE VALVE CALCIFICATION LIKELY CAUSED OR CONTRIBUTED TO THE SUBSEQUENT MODERATE 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 BY THE EDWARDS TERRITORY MANAGER, DURING A TRANSAORTIC TAVR PROCEDURE THE 23MM SAPIEN VALVE WAS IMPLANTED 80:20 AORTIC. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMMEDIATELY AFTER PLACEMENT, SHOWED A MODERATE PARAVALVULAR LEAK (PVL). THE PATIENT'S HEMODYNAMICS ALSO DETERIORATED AND THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS. THE SURGICAL TEAM DECIDED TO PLACE ANOTHER 23MM SAPIEN VALVE AND IT WAS SUCCESSFULLY PLACED 50:50. TEE SHOWED TRACE PVL AND ACCEPTABLE HEMODYNAMICS. THE PATIENT WAS TAKEN OFF OF BYPASS AND THE CHEST INCISION WAS CLOSED. THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION. ADDITIONAL INFORMATION REVEALED THE FOLLOWING: THE AORTIC ROOT WAS FREE OF CALCIFICATION, THE NATIVE LEAFLETS HAD SEVERE CALCIFICATION, AND THERE WAS MODERATE VENTRICULAR SEPTAL HYPERTROPHY. DURING DEPLOYMENT, VENTILATION WAS HELD, BALLOON INFLATION WAS HELD FOR THREE OR MORE SECONDS, AND PACING CAPTURE WAS NOT LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88703 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention