BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2974327 · Received February 22, 2013

    Report

    Report Number
    2015691-2013-19354
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT WAS NOTED TO HAVE BULKY CALCIFICATION OF THE NATIVE VALVE AND LEAFLETS, ALONG WITH SEVERE AORTIC ROOT CALCIFICATION. PRIOR TO DEPLOYMENT OF THE FIRST SAPIEN VALVE THE IMAGE INTENSIFIER ANGLE, AND THE COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND VALVE, WERE REPORTED TO BE GOOD. DURING DEPLOYMENT, VENTILATION WAS HELD AND, THERE WAS NO LOSS OF PACING CAPTURE. PER THE INSTRUCTIONS FOR USE (IFU) COMPLICATIONS ASSOCIATED WITH THE USE OF BIOPROSTHETIC HEART VALVES INCLUDE PARAVALVULAR 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. THE PHYSICIANS 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. THE PHYSICIANS ARE ALSO TRAINED TO CONSIDER PATIENT FACTORS SUCH AS, SIGNIFICANT VALVE OVER-SIZING (= 4 MM), SEVERE SEPTAL HYPERTROPHY, MINIMAL VALVE/LEAFLET CALCIFICATION, AND PRESERVED EJECTION FRACTION (EF). TECHNICAL CONSIDERATIONS INCLUDE SUB-OPTIMAL IMAGE INTENSIFIER (I/I) ANGLE, 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. IN THIS CASE, THE ROOT CAUSE OF THE REPORTED PVL EVENT, AS DISCUSSED BY THE OPERATORS, APPEARS TO BE FROM THE BULKY CALCIUM IN THE LCC. IN GENERAL THIS PATIENT WAS NOTED TO HAVE BULKY CALCIFICATION OF THE NATIVE AORTIC VALVE AND LEAFLETS. 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.

    Description of Event or Problem · 1

    AS REPORTED VIA THE EDWARDS CLINICAL SPECIALIST, DURING A TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, POST DEPLOYMENT OF THE EDWARDS SAPIEN VALVE MODERATE TO SEVERE PARAVALVULAR (PVL) WAS NOTED. AN OPEN AVR WAS PERFORMED TO EXPLANT THE SAPIEN VALVE AND A SURGICAL AORTIC VALVE WAS SUCCESSFULLY IMPLANTED. ACCORDING TO THE CASE SUMMARY, THIS PATIENT WAS NOTED TO HAVE A HEAVILY CALCIFIED ANNULUS WITH MEASUREMENT 23.7 MM BY TEE IMAGING. THE VALVE WAS DEPLOYED IN A 50:50 POSITION WITH STANDARD PREP PER THE IFU RESULTING IN MODERATE TO SEVERE PVL. 1CC WAS ADDED TO THE ATRION AND POST DILATED WITH NO CHANGE. THE PATIENT REMAINED STABLE BUT WAS SLOW TO RECOVER FROM PACING WITH THE POST DILATION. THE PATIENT WAS PLACED ON CPB AND AN ADDITIONAL 1/2 CC WAS ADDED TO THE ATRION AND POST DILATED ONCE MORE WITH NO DECREASE IN PVL. THE PHYSICIAN DECIDED AT THAT POINT TO EXPLANT THE SAPIEN VALVE AND PROCEED WITH AN OPEN SURGICAL AVR. THE PHYSICIAN NOTED THAT THE LEAK WAS FROM A PEA SIZED CHUNK OF CALCIUM ON THE NATIVE LEAFLET. ADDITIONALLY, IT WAS NOTED THAT THE SAPIEN VALVE WAS FULLY EXPANDED AND HAD NO DAMAGE. THE PHYSICIAN HAD DIFFICULTY REMOVING THE NATIVE LEAFLETS DUE TO HEAVY BULKY CALCIUM. A SURGICAL AORTIC VALVE WAS PLACED AND THE SURGERY WAS DEEMED SUCCESSFUL. THE PATIENT WAS NOTED TO BE STABLE AND ALIVE TWO DAYS S/P TAVR PROCEDURE. PER THE PHYSICIAN ASSESSMENT THE CAUSE OF THE MODERATE TO SEVERE PVL WAS DUE TO BULKY CALCIUM IN THE LCC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77752 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26 3085347

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention