BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2922833 · Received January 18, 2013

    Report

    Report Number
    2015691-2013-19147
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. ACCORDING TO THE INSTRUCTIONS FOR USE, PARAVALVULAR LEAK IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE AND THE SAPIEN VALVE. 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 EDWARDS SAPIEN RETROFLEX 3 TRANSFEMORAL DELIVERY SYSTEM TRAINING GUIDE INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. IN THIS CASE THE FIRST VALVE WAS IMPLANTED IN THE PROPER POSITION; HOWEVER, THE PATIENT HAD SEVERE NATIVE VALVE/LEAFLET CALCIFICATION. IT IS LIKELY THAT DISTRIBUTION OF THE CALCIFICATION CAUSED OR CONTRIBUTED TO THE REPORTED PVL. THE LEAK WAS REDUCED TO TRACE WITH DEPLOYMENT OF A 2ND VALVE SLIGHTLY MORE AORTIC. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR 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.

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS CLINICAL SPECIALIST, AFTER DEPLOYMENT OF A 26MM SAPIEN VALVE, THERE WAS SIGNIFICANT PARAVALVULAR LEAK (PVL) REQUIRING DEPLOYMENT OF A SECOND VALVE. ADDITIONAL INFORMATION REVEALED THAT DUE TO POOR FEMORAL ACCESS, THERE WAS A DISCUSSION ABOUT USING A TRANSAPICAL APPROACH. HOWEVER, DUE TO THE PATIENT'S BAD LUNGS (SEVERE COPD) THE TEAM OPTED FOR A RIGHT-SIDE CONDUIT VIA THE RCIA. THE CONDUIT PERFORMED AS EXPECTED AND THERE WERE NO ACCESS ISSUES. THE CASE WENT AS PLANNED AND THE 26 SAPIEN VALVE WAS PLACED WHERE THE PHYSICIAN INTENDED IT TO BE PLACED (50:50). HOWEVER, ON ECHO, THE 2 SIGNIFICANT JETS (+3 PVL) WERE NOTED. THEY RE-BALLOONED WITH A 26MM BALLOON BUT THE PVL REMAINED SERIOUS. THE DECISION WAS MADE TO PLACE A SECOND SAPIEN INSIDE OF THE FIRST ONE, A FEW MILLIMETERS HIGHER. THE SECOND VALVE WAS SUCCESSFULLY PLACED AND THE +3 PVL WAS REDUCED TO TRACE. THE PATIENT HAD A GOOD OUTCOME AND IS DOING WELL. ADDITIONAL INVESTIGATION REVEALED THE FOLLOWING: THE NATIVE ANNULUS DIAMETER WAS 25MM. THE PATIENT'S AORTIC ROOT WAS MILDLY CALCIFIED AND THE AORTIC VALVE WAS SEVERELY CALCIFIED. THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WAS DESCRIBED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27433 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26W

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention