BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2931574 · Received January 28, 2013

    Report

    Report Number
    2015691-2013-19164
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE DEVICE'S INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES INCLUDE BUT ARE NOT LIMITED TO DEVICE MALPOSITION AND AORTIC INSUFFICIENCY. THERE ARE SEVERAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO AORTIC MALPOSITION, INCLUDING IMPROPER SIZING OF THE VALVE, IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMAL VALVE CALCIFICATION, AND LOSS OF PACING CAPTURE. DEPLOYMENT OF THE SAPIEN VALVE TO AORTIC HAS THE POTENTIAL TO CONTRIBUTE TO SUBOPTIMAL COAPTATION OF THE SAPIEN VALVE LEAFLETS WHICH CAN CAUSE CENTRAL AORTIC INSUFFICIENCY. PARAVALVULAR LEAK CAN OCCUR AS A RESULT OF DEVICE MALPOSITION AND/OR A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE WHICH CAN OCCUR DUE TO UNEVEN DISTRIBUTION OF CALCIUM. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING INCLUDES DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICE AT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR TO THE PLACEMENT AND FIXATION OF THE DEVICE. IN THIS CASE, PATIENT AND PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO THE EVENT. PER REPORT, THE ROOT CAUSE OF THIS EVENT WAS ATTRIBUTED TO INITIALLY PLACING THE VALVE TOO HIGH, BUT THERE IS NO CLEAR CAUSE AS TO WHY THE VALVE MOVED AORTIC DURING DEPLOYMENT. IT IS POSSIBLE THAT THE PATIENT'S PRESERVED LV FUNCTION (EF 55%) AND FAIR IIA AND COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND VALVE DURING DEPLOYMENT COULD HAVE CONTRIBUTED TO THE AORTIC MALPOSITION. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. THE IFU AND EDWARDS THV PATIENT SCREENING 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 PREVENTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS TERRITORY MANAGER, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE 26MM SAPIEN TRANSCATHETER HEART VALVE WAS DEPLOYED TO AORTIC CAUSING MODERATE TO SEVERE PARAVALVULAR LEAK (PVL) AND CENTRAL AORTIC INSUFFICIENCY (CAI). A SECOND SAPIEN VALVE WAS IMPLANTED MORE VENTRICULAR IN ORDER TO MITIGATE THE AORTIC INSUFFICIENCY. THE PATIENT'S OUTCOME POST TAVR WAS REPORTED AS STABLE. PER REPORT, THE FIRST SAPIEN VALVE WAS POSITIONED 60:40 FOR DEPLOYMENT AND A PACING RUN WAS COMPLETED TO TEST POSITIONING. UPON DEPLOYMENT, THE VALVE MOVED 90:10 AORTIC. FOLLOWING DEPLOYMENT THERE WAS MODERATE/SEVERE PVL AND DECISION WAS MADE TO POST-DILATE. ONE (1CC) WAS ADDED TO DELIVERY SYSTEM AND THE SAPIEN VALVE WAS POST-DILATED. PVL DID NOT IMPROVE AND CENTRAL AORTIC INSUFFICIENCY WAS NOTED. THE WIRE WAS REMOVED AND THE CAI WAS STILL PRESENT. A SECOND VALVE WAS PREPPED AND DEPLOYED 2MM MORE VENTRICULAR, RESULTING IN ZERO CAI AND MILD PVL. DURING THIS CASE THE IMAGE INTENSIFIER ANGLE (IIA) AND COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND THE VALVE WAS DESCRIBED AS FAIR. VENTILATION WAS HELD AND THERE WAS NO LOSS OF PACING CAPTURE DURING VALVE DEPLOYMENT. THE PATIENT'S NATIVE VALVE, LEAFLET AND AORTIC ROOT CALCIFICATION WAS REPORTED AS MODERATE. THERE WAS NO MITRAL ANNULAR CALCIFICATION OR VENTRICULAR SEPTAL HYPERTROPHY. PER THE INITIAL REPORTER, THE ROOT CAUSE OF THIS EVENT WAS ATTRIBUTED TO INITIALLY PLACING THE VALVE TOO HIGH (AORTIC), AND THEN THE VALVE MOVED FURTHER UP (AORTIC) DURING DEPLOYMENT. WITH THESE CONSIDERATIONS AND THE AORTIC INSUFFICIENCY AT HAND, THE PHYSICIAN THOUGHT IT WOULD BE BEST TO PLACE A SECOND VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36949 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention