BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3041411 · Received April 8, 2013

    Report

    Report Number
    2015691-2013-19769
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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. THERE WAS REPORTED MODERATE VALVE CALCIFICATION WHICH IN COMBINATION WITH THE SLIGHT AORTIC MOVEMENT DURING VALVE DEPLOYMENT MAY HAVE CONTRIBUTED TO THE MODERATE PVL ON INITIAL VALVE DEPLOYMENT. 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

    IT WAS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, THAT DURING THE INSERTION OF THE ASCENDRA SHEATH THE PATIENT'S BLOOD PRESSURE DROPPED TO 80/40. THE ANESTHESIOLOGIST ADMINISTERED VASOPRESSORS AND BAV WAS PERFORMED UNDER RVP. THE PATIENT'S BLOOD PRESSURE REMAINED AT 60/30 AFTER COMPLETION OF BAV. THE PATIENT SOMEWHAT STABILIZED FOR A SHORT PERIOD OF TIME WITH MEDICATION TITRATION. A 23MM SAPIEN VALVE WAS IMPLANTED AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED THE VALVE IN A 70:30 AORTIC POSITION WITH MODERATE PARAVALVULAR LEAK (PVL). POST DILATION OF THE VALVE, WITH THE ADDITION OF 1CC TO THE BALLOON, DID NOT PRODUCE A MARKED CHANGE IN THE PVL. THE PATIENT WAS UNSTABLE AGAIN REQUIRING PACING, CPR, AND BYPASS SUPPORT. THE TAVR TEAM ELECTED TO PLACE A SECOND VALVE 4MM VENTRICULAR TO THE FIRST TO CORRECT THE PVL. THERE WAS IMPROVED MODERATE PV;L HOWEVER, POST DILATION WAS PERFORMED AND THIS REDUCED THE PVL TO MILD. THE SURGICAL SITE WAS SUTURED AND CLOSED. THE PATIENT WAS REMOVED FROM CPB AND TRANSFERRED TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142699 SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Required Intervention