BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2802310 · Received October 24, 2012

    Report

    Report Number
    2015691-2012-18530
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    THE SAFETY AND EFFECTIVENESS OF THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE VIA TRANSEPTAL DELIVERY HAS NOT BEEN ESTABLISHED, IS NOT AN APPROVED METHOD OF DELIVERY FOR THE SAPIEN VALVE IN THE UNITED STATES, NOR IS IT ENDORSED OR RECOMMENDED BY EDWARDS LIFESCIENCES. PER THE DEVICE INSTRUCTIONS FOR USE (IFU), VALVE DEPLOYMENT IN UNINTENDED LOCATION, PARAVALVULAR OR TRANSVALVULAR LEAK, AND MALPOSITION REQUIRING INTERVENTION ARE POTENTIAL RISKS ASSOCIATED WITH THE USE OF THE BIOPROSTHESIS. 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. THERE ARE SEVERAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VALVE MALPOSITION. ACCORDING TO THE PHYSICIAN'S TRAINING MANUAL, SOME FACTORS THAT CAN CONTRIBUTE TO VALVE MALPOSITION ARE POOR POSITIONING BY OPERATOR, ANNULUS-VALVE MISMATCH (UNDER SIZING AND UNDER DILATION), INTERFERENCE FROM ADJACENT STRUCTURES (I.E. SUB-AORTIC HYPERTROPHY), AND BALLOON MOVEMENT DURING DEPLOYMENT (I.E. INADEQUATE REDUCTION OF TRANSVALVULAR FLOW DUE TO LOSS OF PACING CAPTURE DURING BALLOON INFLATION). IMAGING AND MEDICAL RECORDS FOR THIS CASE WERE REQUESTED BY EDWARDS LIFESCIENCES FOR FURTHER EVALUATION OF THE EVENT. HOWEVER, TO DATE, THE HOSPITAL HAS NOT PROVIDED ANY ADDITIONAL INFORMATION. IN THIS PARTICULAR CASE, THE CAUSE OF THE REPORTED VALVE MALPOSITION AND SUBSEQUENT EMBOLIZATION CANNOT BE CANNOT BE CONFIRMED/ASSESSED AS ADDITIONAL INFORMATION AND IMAGES OF THE PROCEDURE WERE NOT MADE AVAILABLE TO EDWARDS FOR REVIEW. SPECIFICALLY, WITHOUT IMAGING, PATIENT FACTORS (I.E. ANNULAR DIAMETER, VALVE CALCIFICATION, SINOTUBULAR JUNCTION CALCIFICATION, PRESENCE OF SEPTAL HYPERTROPHY), AND PROCEDURAL FACTORS (IMAGING INTENSIFIER ANGLE, VALVE POSITIONING PRIOR DEPLOYMENT, ADEQUACY OF PACING DURING DEPLOYMENT), CANNOT BE ASSESSED. HOWEVER, IT IS POSSIBLE THAT PROCEDURAL FACTORS (I.E. PER REPORT THE VALVE WAS POSSIBLY CRIMPED TO A NON-EDWARDS BALLOON AND DEPLOYED VIA TRANS-SEPTAL APPROACH) MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. 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

    THIS REPORT IS REGARDING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) CASE BY TRANSEPTAL APPROACH. IT IS BELIEVED THAT THE FIRST 2 SAPIEN VALVES DEPLOYED IN THE AORTIC ANNULUS WERE CRIMPED TO A NON-EDWARDS BALLOON; HOWEVER, THIS INFORMATION HAS NOT YET BEEN CONFIRMED. THE FIRST SAPIEN VALVE WAS DEPLOYED TOO AORTIC AND EMBOLIZED IN TO THE AORTA. A SECOND SAPIEN VALVE, VIA THE SAME TRANSEPTAL APPROACH, WAS ALSO DEPLOYED TOO AORTIC AND EMBOLIZED. THERE IS NO INFORMATION ON WHERE THESE VALVES WERE SECURED. A THIRD SAPIEN VALVE WAS CRIMPED ONTO A RETROFLEX3 DELIVERY SYSTEM AND WAS DEPLOYED IN GOOD POSITION VIA TRANS-AORTIC APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SAPIEN TRANSCATHETER HEART VALVE TISSUE, HEART-VALVE LWR EDWARDS LIFESCIENCES 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention