BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2922583 · Received January 18, 2013

    Report

    Report Number
    2015691-2013-19143
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER REPORT, THE SITE IS NEW TO THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE AND OPERATOR TECHNIQUE MAY HAVE CONTRIBUTED TO THE EVENT; HOWEVER, THE EXACT PROCEDURAL TECHNIQUE WHICH MAY HAVE CONTRIBUTED TO THE AORTIC MALPOSITION COULD NOT BE CONFIRMED. THE FCS AND THE PROCTOR DISCUSSED WAYS TO PREVENT IMPLANTING THE SAPIEN VALVE TOO AORTIC IN FUTURE CASES. PER THE INSTRUCTIONS FOR USE, DEVICE MALPOSITION REQUIRING INTERVENTION AND VALVE REGURGITATION ARE 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. IN ADDITION, THE PATIENT SCREENING MANUAL AND THE PROCEDURE DIDACTIC IDENTIFY SEVERAL PROCEDURAL AND ANATOMICAL FACTORS WHICH COULD CONTRIBUTE TO PARAVALVULAR LEAK, INCLUDING DEVICE MALPOSITIONING, INACCURATE MEASUREMENT OF THE NATIVE VALVE ANNULUS, IMPROPER VALVE SIZING, AND UNEVEN DISTRIBUTION OF CALCIUM ON THE NATIVE VALVE. THE PROCEDURAL DIDACTIC INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BE EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (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. ALTHOUGH IT CANNOT BE CONFIRMED, IT WAS REPORTED THAT OPERATOR TECHNIQUE MAY HAVE CONTRIBUTED TO THE AORTIC MALPOSITION, HOWEVER, THE SPECIFICS ARE NOT CLEAR. THE 70:30 AORTIC PLACEMENT LIKELY CAUSED THE PVL. THE PVL WAS REDUCED TO TRACE BY THE IMPLANTATION OF A SECOND SAPIEN VALVE. 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 (FCS), THE 26MM SAPIEN VALVE WAS POSITIONED 50:50 ACROSS THE NATIVE AORTIC ANNULUS. HOWEVER, POST DEPLOYMENT THE SAPIEN VALVE WAS POSITIONED 2-3MM ABOVE (AORTIC) THE INITIAL TARGET AREA, RESULTING IN MODERATE PARAVALVULAR LEAK (PVL) AND SEVERE AORTIC REGURGITATION. ELEVATED PA PRESSURES AND HYPOTENSION WERE NOTED. A SECOND 26MM SAPIEN VALVE WAS SUCCESSFULLY IMPLANTED MORE VENTRICULAR INSIDE THE FIRST SAPIEN VALVE. THE FINAL RESULT WAS TRACE PVL. FOLLOWING THE PROCEDURE, THE PATIENT WAS NOTED TO BE IN STABLE CONDITION ADDITIONAL INVESTIGATION REVEALED THE FOLLOWING: THERE WAS NO SEPTAL HYPERTROPHY OR MITRAL ANNULAR CALCIFICATION (MAC). THE NATIVE AORTIC VALVE WAS MODERATE-SEVERELY CALCIFIED. THE IMAGE INTENSIFIER ANGLE AND COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WERE BOTH DESCRIBED AS GOOD. POST DEPLOYMENT, THE FIRST SAPIEN VALVE WAS POSITIONED APPROXIMATELY 70:30 AORTIC. DURING VALVE DEPLOYMENT, BALLOON INFLATION WAS HELD FOR THREE OR MORE SECONDS AND THERE WAS NO LOSS OF PACING CAPTURE. VENTILATION WAS NOT HELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27407 EDWARDS SAPIEN TRANSCATHETER HEART VALVE TRANSCATHETER HEART VALVE LWR EDWARDS LIFESCIENCES 9000TFX26 3065879

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention