BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3002889 · Received March 13, 2013

    Report

    Report Number
    2015691-2013-19537
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT; HOWEVER, THERE IS NO ALLEGATION OF DEVICE MALFUNCTION. PER THE INSTRUCTIONS FOR USE, DEVICE MALPOSITION REQUIRING INTERVENTION AND VALVE REGURGITATION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE SEVERAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO AORTIC MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE OR DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMAL VALVE CALCIFICATION, AND LOSS OF PACING CAPTURE. THE PROCEDURAL DIDACTIC INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. 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, THE ROOT CAUSE FOR THE AORTIC MALPOSITION WAS REPORTED TO BE DUE TO THE SEVERELY HORIZONTAL AND TORTUOUS AORTA CAUSING DIFFICULTY IN POSITIONING THE VALVE, AND TOO AORTIC POSITION PRIOR TO DEPLOYMENT. THIS IN COMBINATION WITH THE SEVERELY CALCIFIED VALVE LIKELY CAUSED OR CONTRIBUTED TO THE SEVERE PVL ON INITIAL VALVE DEPLOYMENT. 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TAVR PROCEDURE THE SAPIEN VALVE WAS IMPLANTED 90:10 AORTIC AND CANTED TOWARD THE RIGHT CORONARY ARTERY. THIS CREATED SEVERE PARAVALVULAR LEAK (PVL) IN MULTIPLE AREAS. A SECOND SAPIEN VALVE WAS IMPLANTED MORE VENTRICULAR WITH A GREAT OUTCOME. VALVULOPLASTY WAS PERFORMED USING THE EDWARDS 23MM X 4 CM BAVC BALLOON WITHOUT INCIDENT. THE VALVE WAS INSERTED THROUGH THE SHEATH AND ADVANCED AROUND THE AORTA. IT WAS REPORTED THAT THE PATIENT HAD AN EXTREMELY TORTUOUS AND UNFOLDED AORTA WHICH MADE REACHING THE NATIVE VALVE AND POSITIONING THE SAPIEN VALVE DIFFICULT. THE NATIVE LEAFLETS AND AORTIC ROOT HAD SEVERE CALCIFICATION. THE ENTIRE LOADER HAD TO BE REMOVED IN ORDER FOR THERE TO BE ENOUGH LENGTH IN THE CATHETER TO CROSS THE VALVE. THE BEST AVAILABLE ANGIOGRAPHIC PROJECTION WAS AP WITH 27 CRANIAL. THE THREE CUSPS WERE IN GOOD ALIGNMENT BUT THIS WAS AN UNUSUAL PROJECTION DUE TO THE EXTREMELY HORIZONTAL AORTA. THE TEAM HAD TO SWITCH FROM A 100CM JR4 CATHETER TO A 110CM VERTEBRAL CATHETER BECAUSE THE EXTREMELY TORTUOUS AORTA CAUSED THE INITIAL CATHETER TO BE TOO SHORT TO CROSS THE NATIVE VALVE. MULTIPLE ATTEMPTS WERE MADE TO POSITION THE VALVE. THE VALVE WAS DEPLOYED IN WHAT WAS ASSUMED TO BE A GOOD DEPLOYMENT POSITION; HOWEVER, IN RETROSPECT WAS VERY AORTIC. AN AORTIC ROOT ANGIOGRAM SHOWED NO CONTRAST FLOW INTO THE LEFT CORONARY SYSTEM AND THERE WERE SOME ST SEGMENT CHANGES. A SECOND VALVE WAS PREPARED AND DEPLOYED 50% LOWER THAN THE FIRST AND DEPLOYED AS POSITIONED. THE VALVES RECENTERED A BIT. THE PVL WAS REDUCED FROM SEVERE TO MILD. AN AORTIC ROOT ANGIOGRAM SHOWED PATENT CORONARY ARTERIES. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS AND REPORTEDLY THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105474 SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention