BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3250013 · Received July 26, 2013

    Report

    Report Number
    2015691-2013-20685
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED FROM THE OPERATIVE REPORT INDICATED THAT THE POST DEPLOYMENT ECHOCARDIOGRAM OF THE FIRST VALVE SHOWED SEVERE AORTIC INSUFFICIENCY WITH POSTERIOR AND ANTERIOR PARAVALVULAR LEAK (PVL) DESPITE POSTDILATION. THE SECOND 26MM SAPIEN VALVE WAS POSITIONED LOWER THAN THE PREVIOUS 26MM VALVE AND DEPLOYED UNDER RAPID PACING. POST DEPLOYMENT, THERE WAS MILD TO MODERATE AORTIC INSUFFICIENCY. THE ACCESS SITE WAS ABLE TO BE CLOSED. THE PATIENT WAS EXTUBATED AND WAS NOTED TO HAVE TOLERATED THE PROCEDURE WELL. 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. THE PHYSICIANS UNDERGO EXTENSIVE TRAINING BY EDWARDS LIFESCIENCES IN ORDER TO PERFORM THV PROCEDURES. TRAINING INCLUDES DEVICE PREPARATION, APPROACH, POSITIONING AND DEPLOYMENT, IMAGING, AND PROCTORED PROCEDURES. THE PHYSICIAN¿S TRAINING MANUALS INSTRUCT THE PHYSICIAN ON THE PROPER STEPS AND TECHNIQUES FOR SUCCESSFUL VALVE DEPLOYMENT. PHYSICIANS ARE TRAINED TO TAKE INTO ACCOUNT 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 IMPROPER 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 EXACT CAUSE OF THE AORTIC REGURGITATION (CENTRAL AND PVL) CANNOT BE DETERMINED, HOWEVER, THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. ADDITIONALLY, POST TAVR TEE DEMONSTRATED TRACE TO MILD PERIVALVULAR LEAK SO THE INITIAL AR HAD REDUCED POST PROCEDURE. IN THIS CASE, IT IS POSSIBLE THAT PATIENT AND PROCEDURAL FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. 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.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, IT IS UNKNOWN WHICH OF THE INFORMATION PROVIDED PERTAINS TO THE FIRST VALVE THAT WAS IMPLANTED. ON THIS BASIS, THE INFORMATION FOR BOTH VALVES IS BEING PROVIDED: [MODEL # 9000TFX26/SERIAL# (B)(4)/LOT# 59372187/ MFG. 10/16/2012/EXP. 08/29/2014] [MODEL # 9000TFX26/SERIAL# (B)(4)/LOT#59405889 /MFG. 02/05/2013 /EXP. 12/10/2014]. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED THROUGH THE PATIENT REGISTRY, DURING THE TAVR PROCEDURE THE DECISION WAS MADE TO DEPLOY A SECOND 26MM SAPIEN VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350384 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention