BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2874759 · Received December 16, 2012

    Report

    Report Number
    2015691-2012-18864
    Event Type
    Injury
    Date Received
    December 16, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS NOTED TO HAVE MODERATE NATIVE VALVE AND LEAFLET CALCIFICATION AND MILD SEPTAL HYPERTROPHY. AT THE TIME OF DEPLOYMENT OF THE 23MM SAPIEN VALVE, WITHIN A 21.5MM ANNULUS, THE VALVE WAS POSITIONED 40:60 / 30:70. THERE WAS REPORTED FAIR 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. POST DEPLOYMENT THE SAPIEN VALVE WAS NOTED TO BE IN A 20:80 VENTRICULAR POSITION. IMAGING IS PENDING SUBMISSION FROM THE HOSPITAL TO ASSESS FOR A POSSIBLE ROOT CAUSE OF THE REPORTED EVENT. INVESTIGATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    CINE AND ECHO (TTE) IMAGES WERE SUBMITTED FOR REVIEW. TTE IMAGES WERE FROM THE DAY AFTER PROCEDURE· THE OBSERVATIONS ARE AS FOLLOWS: MODERATE AORTIC VALVE CALCIFICATION, MILD AORTIC ROOT CALCIFICATION, NO PORCELAIN AORTA, MOD-SEVERE MAC; GOOD COAXIAL ALIGNMENT OF VALVE; GOOD IMAGE INTENSIFIER ANGLE (IIA) · VALVE POSITIONING 35/65 VENTRICULAR PRIOR TO DEPLOYMENT POST VALVE DEPLOYMENT THE VALVE IS 20/80 ON THE MEDIAL ASPECT; POST DEPLOYMENT AORTOGRAM DEMONSTRATES SIGNIFICANT AR; SUBSEQUENTLY VALVE EMBOLIZES TO THE LV · A SECOND VALVE IS DEPLOYED 70/30 AORTIC; POST AORTOGRAPHY OF 2ND VALVE DEMONSTRATES AR. THE IMPRESSIONS ARE AS FOLLOWS: GOOD IMAGE INTENSIFIER ANGLE AND GOOD COAXIAL ALIGNMENT OF DELIVERY SYSTEM AND VALVE; HOWEVER, LONGITUDINAL POSITIONING OF THE VALVE WAS TOO VENTRICULAR PRIOR TO DEPLOYMENT, RESULTING IN TOO VENTRICULAR POSITION OF THE VALVE POST DEPLOYMENT, AND SUBSEQUENT EMBOLIZATION INTO THE LV. PER THE INSTRUCTIONS FOR USE (IFU) COMPLICATIONS ASSOCIATED WITH THE USE OF BIOPROSTHETIC HEART VALVES INCLUDE VALVE MALPOSITION. 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, FROM THE IMPRESSIONS OF THE IMAGING, IT APPEARS THAT PROCEDURAL FACTORS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A COMPLAINT HISTORY FOR THESE TYPES OF EVENTS 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.

    Description of Event or Problem · 1

    AS REPORTED VIA THE EDWARDS CLINICAL SPECIALIST (CS), DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, UPON DEPLOYMENT THE EDWARDS SAPIEN VALVE, THE VALVE MOVED SLIGHTLY UP AND THEN DOWN TO A 20:80 VENTRICULAR POSITION. THE PATIENT WAS NOTED TO HAVE SEVERE REGURGITATION AND THE SAPIEN VALVE WAS FOUND TO BE BARELY HANGING IN THE ANNULUS. WHEN CROSSING THE VALVE IN AN ATTEMPT TO DEPLOY A SECOND SAPIEN VALVE TO SECURE FIRST VALVE, THE VALVE DISLODGED AND EMBOLIZED INTO THE LEFT VENTRICLE (LV). THE 2ND SAPIEN VALVE WAS DEPLOYED 50:50 AND THE AI WAS NOTED TO BE TRACE TO MILD. A STERNOTOMY WAS PERFORMED AND THE EMBOLIZED VALVE WAS SURGICALLY REMOVED. ACCORDING TO THE CASE SUMMARY, A CUT DOWN WAS PERFORMED, AND A RETROFLEX3 SHEATH WAS PLACED SUCCESSFULLY. A BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A ZMED BALLOON AND POST BAV SEVERE AORTIC INSUFFICIENCY (AI) WAS NOTED. A 23MM SAPIEN VALVE WAS POSITIONED STARTING IN A 40:60 / 30:70 POSITION. DURING DEPLOYMENT THE SAPIEN VALVE MOVED SLIGHTLY UP AND THEN DOWN AND ENDED UP IN A 20:80 VENTRICULAR POSITION. THE AI WAS STILL SEVERE AND THE SAPIEN WAS NOTED TO BE HANGING IN THE ANNULUS BY A HAIR. A 2ND SAPIEN VALVE WAS PREPPED AND AT THE TIME OF CROSSING THE 1ST SAPIEN VALVE, THE VALVE DISLODGED AND EMBOLIZED INTO THE LEFT VENTRICLE (LV). THE 2ND SAPIEN WAS DEPLOYED 50:50 AND THE AI WAS NOTED TO BE TRACE TO MILD. A STERNOTOMY WAS PERFORMED AND THE 1ST SAPIEN VALVE WAS REMOVED FROM THE LV, THROUGH THE MITRAL VALVE AND, OUT THROUGH THE LEFT ATRIUM. THE STERNOTOMY AND CUTDOWN WERE CLOSED, THE PATIENT WAS EXTUBATED, AND WAS NOTED TO BE IN A STABLE CONDITION.

    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 84 YR