BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2873127 · Received December 13, 2012

    Report

    Report Number
    2015691-2012-18852
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 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

    THIS PATIENT WAS NOTED TO HAVE A MODERATELY CALCIFIED NATIVE AORTIC ROOT AND LEAFLETS. PER THE INSTRUCTIONS FOR USE (IFU) COMPLICATIONS ASSOCIATED WITH THE USE OF BIOPROSTHETIC HEART VALVES INCLUDE PARAVALVULAR LEAK AND CENTRAL LEAK. SOME PVL IS EXPECTED POST DEPLOYMENT. MANY CASES ARE MILD TO MODERATE, AND EITHER RESOLVES OVER TIME OR DO NOT CAUSE SYMPTOMS. OTHERS MAY BE MORE CLINICALLY SIGNIFICANT AND REQUIRE INTERVENTION. IN ADDITION, PER THE IFU, VALVE MALPOSITION IS A KNOWN POTENTIAL COMPLICATION OF THE TAVR PROCEDURE. FACTORS TO CONSIDER WHEN ASSESSING FOR AORTIC VALVE MALPOSITION INCLUDE THE FOLLOWING PATIENT FACTORS, SIGNIFICANT VALVE OVER-SIZING (= 4 MM), SEVERE SEPTAL HYPERTROPHY, MINIMAL VALVE/LEAFLET CALCIFICATION, AND PRESERVED EJECTION FRACTION (EF). TECHNICAL CONSIDERATIONS INCLUDE IMPROPER IMAGE INTENSIFIER (I/I) ANGLE (UNABLE TO VIEW ALL 3 CUSPS IN A PLANE), 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. THE PHYSICIAN'S 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 PHYSICIAN'S TRAINING MANUALS INSTRUCT THE PHYSICIAN ON THE PROPER STEPS AND TECHNIQUES FOR SUCCESSFUL VALVE DEPLOYMENT. THERE WAS NO REPORT OF DEVICE MALFUNCTION THAT RESULTED IN THIS EVENT. IN THIS CASE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE CONFIRMED; HOWEVER, IT IS LIKELY THAT A COMBINATION OF PROCEDURAL (TOO VENTRICULAR VALVE DEPLOYMENT) AND PATIENT FACTORS (MODERATELY CALCIFIED AORTIC ROOT AND LEAFLETS) COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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 PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE FIRST SAPIEN VALVE WAS POSITIONED 60:40 VENTRICULAR WITHIN THE NATIVE ANNULUS PRIOR TO DEPLOYMENT. THERE WAS REPORTED GOOD IMAGE INTENSIFIER ANGLE AND COAXIAL ALIGNMENT OF THE VALVE AND THE DELIVERY SYSTEM PRIOR TO DEPLOYMENT OF THE VALVE. VENTILATION WAS HELD DURING VALVE DEPLOYMENT AND THERE WAS NO LOSS OF PACING CAPTURE DURING DEPLOYMENT OF THE FIRST SAPIEN VALVE. INVESTIGATION FOR A POSSIBLE ROOT CAUSE PF THE REPORTED EVENT IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED VIA THE EDWARDS CLINICAL SPECIALIST, POST DEPLOYMENT OF THE EDWARDS SAPIEN VALVE DURING A TRANSAPICAL TAVR PROCEDURE, SEVERE AORTIC REGURGITATION (AR) WAS NOTED AND THE VALVE APPEARED TO BE DEPLOYED TOO LOW IN THE ANNULUS. A SECOND VALVE WAS DEPLOYED MORE AORTIC AND RESOLVED THE ISSUE. THE PATIENT WAS TRANSFERRED TO THE ICU POST PROCEDURE. ACCORDING TO THE CASE SUMMARY, THE PATIENT WAS PREPPED AND DRAPED IN A USUAL STERILE MANNER. A LEFT THORACOTOMY WAS PERFORMED TO GAIN APICAL ACCESS. A BAV WAS PERFORMED WITH AN EDWARDS BALLOON WITH NO NOTED ISSUES. THE 23MM SAPIEN VALVE WAS INTRODUCED AND POSITIONED. THE VALVE WAS DEPLOYED ACCORDING TO THE DEPLOYMENT STEPS. ONCE THE VALVE WAS DEPLOYED AN ANGIOGRAM WAS PERFORMED AND SHOWED SEVERE AR AND THE VALVE APPEARED TO HAVE BEEN DEPLOYED TOO LOW IN THE ANNULUS. A SECOND VALVE WAS PREPPED AND DEPLOYED MORE AORTIC THAN THE FIRST VALVE. POST DEPLOYMENT AN ANGIOGRAM WAS PERFORMED AND SHOWED MILD TO NO AR. THE DELIVERY SYSTEM AND SHEATH WERE REMOVED. THE CHEST WAS CLOSED AND THE PATIENT WAS TRANSFERRED TO THE ICU.

    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 59087952

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention