BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VLV (23MM)

    MDR report key: 5813969 · Received July 21, 2016

    Report

    Report Number
    2015691-2016-02298
    Event Type
    Injury
    Date Received
    July 21, 2016
    Date of Event
    June 30, 2016
    Report Date
    July 3, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), VALVE MALPOSITION AND EMBOLIZATION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VALVE MALPOSITION/EMBOLIZATION, INCLUDING, BUT NOT LIMITED TO, IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, LOSS OF PACING CAPTURE, RAPID DEPLOYMENT AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. THE EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE IS INDICATED FOR PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVE STENOSIS. DEPLOYMENT OF THE SAPIEN XT VALVE IN A PREVIOUSLY IMPLANTED MITRAL SURGICAL VALVE IS NOT INDICATED PER THE LABELING; THEREFORE THE LABELING (IFUS AND EW TRAINING MANUALS) DO NOT INSTRUCT THE OPERATOR HOW TO POSITION THE SAPIEN XT VALVE IN THIS SCENARIO. IN THIS CASE, THE MALPOSITION OF THE VALVE IS LIKELY DUE TO THE MECHANISM DESCRIBED ABOVE. THE MALPOSITION OF THE VALVE LIKELY LEAD TO THE VALVE EMBOLIZATION INTO THE ATRIUM.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATES IN (B)(6), DURING IMPLANT OF A 23MM SAPIEN XT VALVE WITHIN A SURGICAL MOSAIC 25 VALVE IN THE MITRAL POSITION, THE VALVE WAS IMPLANTED IN A TOO ATRIAL POSITION FOR THE PATIENT. WHILE WITHDRAWING THE ASCENDRA+ DELIVERY SYSTEM, THE VALVE EMBOLIZED INTO THE ATRIUM. A SECOND 23MM SAPIEN XT VALVE WAS SUCCESSFULLY IMPLANTED AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM TO REMOVE THE EMBOLIZED VALVE. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464484 EDWARDS SAPIEN XT TRANSCATHETER HEART VLV (23MM) AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention