BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2853601 · Received December 3, 2012

    Report

    Report Number
    2015691-2012-18740
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT. THE EDWARDS SAPIEN RETROFLEX3 DELIVERY SYSTEM IS NOT INDICATED FOR USE VIA A TRANSAPICAL APPROACH; HOWEVER, DEVICE MALPOSITION REQUIRING INTERVENTION AND VALVE REGURGITATION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSAORTIC HEART VALVE REPLACEMENT 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/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 BE 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 CAUSE OF THE AORTIC MOVEMENT UPON VALVE DEPLOYMENT AND SUBSEQUENT CAI CANNOT BE CONFIRMED BASED ON THE AVAILABLE INFORMATION. HOWEVER, IT WAS NOTED THERE WAS MODERATE SEVERE AORTIC VALVE / LEAFLET CALCIFICATION AND THIS ALONG WITH PROCEDURAL FACTORS COULD HAVE CONTRIBUTED TO THE EVENT. OF NOTE, THE SAPIEN VALVE WAS DEPLOYED TRANSAPICALLY USING A RETROFLEX 3 TRANSFEMORAL DELIVERY SYSTEM. THE IFU CLEARLY INDICATES THAT THE RETROFLEX 3 DELIVERY SYSTEM IS LABELED FOR A TRANSFEMORAL RETROGRADE APPROACH. THERE IS NO EVIDENCE AT THIS TIME THAT THE EVENT WAS RELATED TO THE OFF-LABEL USE OF THE DEVICE. 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. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, FOLLOWING DEPLOYMENT OF A SAPIEN VALVE VIA A TRANSAPICAL APPROACH USING A RETROFLEX3 DELIVERY SYSTEM, SEVERE CENTRAL AORTIC INSUFFICIENCY (CAI) WAS NOTED WHICH REQUIRED THE IMPLANTATION OF A SECOND SAPIEN VALVE WITHIN THE FIRST. ADDITIONAL INVESTIGATION REVEALED THE FOLLOWING: THE NATIVE AORTIC VALVE WAS MODERATE TO SEVERELY CALCIFIED. THE SINOTUBULAR JUNCTION HAD A DIAMETER OF 23.9 MM AND WAS MODERATELY CALCIFIED. THE PATIENT'S EJECTION FRACTION WAS 60%. PRIOR TO DEPLOYMENT, THE SAPIEN VALVE WAS POSITIONED 50:50 ACROSS THE NATIVE AORTIC ANNULUS. POST DEPLOYMENT, THE VALVE WAS POSITIONED 70:30 AORTIC. DURING VALVE DEPLOYMENT, BALLOON INFLATION WAS HELD FOR THREE OR MORE SECONDS, AND THERE WAS NO LOSS OF PACING CAPTURE. THE IMAGE INTENSIFIER ANGLE AND THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WERE BOTH DESCRIBED AS GOOD. PER REPORT, DURING DEPLOYMENT THE VALVE MOVED AORTIC. THE OFF LABEL USE OF THE RETROFLEX3 TRANSFEMORAL DELIVERY SYSTEM TO IMPLANT THE VALVE VIA A TRANSAPICAL APPROACH WAS DUE TO THE HOSPITAL'S PREFERENCE, AS REPORTEDLY THEY ONLY PERFORM TRANSAPICAL CASES WITH THE RETROFLEX3 DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SAPIEN TRANSCATHETER HEART VALVE TRANSCATHETER HEART VALVE LWR EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention