BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 4871730 · Received June 26, 2015

    Report

    Report Number
    2015691-2015-01540
    Event Type
    Injury
    Date Received
    June 26, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 4, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), VALVE MALPOSITION AND EMBOLIZATION, AND REGURGITATION, 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. HOWEVER, THERE IS AN ON-LINE APPLICATION (VIV MITRAL) DEVELOPED AND DISTRIBUTED BY SEVERAL WELL KNOWN PHYSICIANS IN THE TAVR COMMUNITY. THE APPLICATION (APP) IS SUPPORTED BY (B)(6). THE APP INCLUDES, BUT IS NOT LIMITED TO, DESIGN AND SIZING INFORMATION FOR SURGICAL AND TRANSCATHETER HEART VALVES, AND GUIDANCE TO HELP CHOOSE A COMPATIBLE VALVE FOR A VALVE-IN-VALVE PROCEDURE. IT IS MEANT TO COMPLEMENT NORMAL PROCEDURES FOR CLINICAL DECISION MAKING. IN REVIEW OF THIS APPLICATION, IT IS NOTED THAT VALVE-IN-VALVE IN THIS SCENARIO (MOSAIC VALVE IN MITRAL POSITION) IS RECOMMENDED WITH EITHER A 26MM OR 29MM SAPIEN VALVE. IN THIS CASE, PER REPORT, THE ATRIAL MIGRATION AND SUBSEQUENT NON-FUNCTIONAL LEAFLET/SIGNIFICANT MR WAS REPORTED BY THE PHYSICIAN TO BE DUE TO EITHER VALVE UNDERSIZING OR THE TOO ATRIAL PLACEMENT OF THE VALVE. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING IMPLANT OF A TRANSCATHETER HEART VALVE (THV) IN A SURGICAL VALVE IN THE MITRAL POSITION, THE THV MIGRATED, RESULTING IN SIGNIFICANT POST-IMPLANT MR. THE PATIENT INITIALLY PRESENTED WITH A FAILING 29MM MOSAIC SURGICAL VALVE AND SEVERE MR. DURING THE PRE-OPERATIVE WORKUP THE MITRAL ¿VALVE IN VALVE APP¿ WAS CONSULTED FOR RECOMMENDATIONS ON VALVE SIZING. RECOMMENDATION WAS THAT EITHER 26MM OR 29MM THV WOULD BE SUITABLE IMPLANT FOR THE 29 MOSAIC VALVE. THE DECISION WAS MADE TO IMPLANT A 26MM SAPIEN XT VALVE VIA TRANSAPICAL APPROACH. DURING DEPLOYMENT, THE SAPIEN XT VALVE MIGRATED TOWARD THE ATRIAL DIRECTION WHICH RESULTED IN A NON-FUNCTIONAL LEAFLET AND SIGNIFICANT POST-IMPLANT MR. THE THV VALVE WAS FULLY EXPANDED PRIOR TO THE MIGRATION. THE DECISION WAS MADE TO IMPLANT A 29MM SAPIEN XT IN A MORE VENTRICULAR POSITION. THE SECOND THV IMPLANT WAS SUCCESSFUL WITH NO SIGNIFICANT MR OR PVL NOTED. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. THE ATRIAL MIGRATION AND SUBSEQUENT NON-FUNCTIONAL LEAFLET/SIGNIFICANT MR WAS REPORTED TO HAVE BEEN CAUSED BY AN UNDERSIZED VALVE OR THE TOO ATRIAL PLACEMENT OF THE THV VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415574 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention