BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3/SAPIEN DELIVERY SYSTEM - 26MM

    MDR report key: 3162306 · Received June 11, 2013

    Report

    Report Number
    2015691-2013-20313
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE INSTRUCTIONS FOR USE (IFU) AND THE PROCEDURE DIDACTIC DETAIL THE STEPS NECESSARY TO SUCCESSFULLY CROSS THE NATIVE VALVE AND ALIGN THE TRANSCATHETER HEART VALVE. PER THE PROCEDURE DIDACTIC, IF DIFFICULTY CROSSING IS EXPERIENCED THE OPERATOR IS ADVISED TO PUT TENSION ON THE WIRE AND PULL THE SYSTEM BACK AND RE-ADVANCE. SEVERAL FACTORS CAN MAKE IT DIFFICULT TO CROSS THE NATIVE VALVE, INCLUDING HEAVY CALCIFICATION, WIRE BIAS INTO COMMISSURE, HORIZONTAL AORTA, TORTUOUS THORACIC AORTA, AND A KINKED FLEX CATHETER. IN ADDITION, THE PROCEDURE DIDACTIC OUTLINES THE STEPS NECESSARY TO ENSURE SMOOTH MOVEMENT OF THE BALLOON CATHETER DURING VALVE ALIGNMENT AND TO MAKE FINE ADJUSTMENTS. IN THIS CASE, IT IS POSSIBLE THAT A COMBINATION OF A FAIR COAXIAL ALIGNMENT, BULKY CALCIFICATION AND A SMALL AORTIC VALVE AREA (.73) CAUSED OR CONTRIBUTED TO THE DIFFICULTY CROSSING THE NATIVE AORTIC VALVE. 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TAVR PROCEDURE THE PHYSICIAN WAS UNABLE TO CROSS THE NATIVE AORTIC VALVE WITH THE RETROFLEX3 DELIVERY SYSTEM DESPITE MULTIPLE ATTEMPTS. THE 26MM SAPIEN VALVE WAS SUBSEQUENTLY IMPLANTED IN THE DISTAL AORTA. FOLLOWING THE TAVR PROCEDURE, THE PATIENT WAS NOTED TO BE IN STABLE CONDITION. PRIOR TO ATTEMPTING TO CROSS THE NATIVE AORTIC VALVE WITH THE DELIVERY SYSTEM, BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH AN EDWARDS 23X4 BAV BALLOON. THERE WAS NO DIFFICULTY CROSSING THE NATIVE AORTIC VALVE WITH THE EDWARDS BAV CATHETER. THE FIRST BAV INFLATION WAS UNSTABLE, BUT THE SECOND INFLATION WAS STABLE. THE FLEX CATHETER WAS NOT KINKED, AND THERE WAS NO GUIDEWIRE BIAS. THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WAS DESCRIBED AS FAIR. THERE WAS NO THORACIC AORTA TORTUOSITY NOTED. THE NATIVE AORTIC ANNULAR DIAMETER WAS 24MM, AND THERE WAS BULKY CALCIFICATION ON THE NATIVE AORTIC VALVE. THE AORTIC VALVE AREA WAS .73.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262279 RETROFLEX 3/SAPIEN DELIVERY SYSTEM - 26MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS26

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention