BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 6758666 · Received August 1, 2017

    Report

    Report Number
    2015691-2017-02294
    Event Type
    Injury
    Date Received
    August 1, 2017
    Date of Event
    July 11, 2017
    Report Date
    July 11, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW UP ECHO (DATE UNKNOWN) IMAGES WERE PROVIDED TO EDWARDS AND REVIEWED BY AN EDWARDS PHYSICIAN PROCTOR. THE FINDINGS ARE SUMMARIZED BELOW: ECHO (DATE UNKNOWN): MOSAIC VALVE SEEN WITH PVL AND CENTRAL AI XT APPEARS SLIGHTLY TOO ATRIAL IMPRESSION/RECOMMENDATIONS: NO IMAGES PROVIDED THAT SHOW ALL 3 XT LEAFLETS TO DETERMINE COAXIALLY. UNABLE TO DETERMINE CAUSE OF CENTRAL AI DUE TO LIMITED IMAGES AND PATIENT INFORMATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION PROVIDED CLARIFIED THAT 8 MONTHS POST IMPLANT OF THE 26MM SAPIEN XT VALVE INSIDE THE SURGICAL MOSAIC VALVE, CENTRAL REGURGITATION WAS OBSERVED BY 3D ECHO. A SAPIEN 3 VALVE WAS IMPLANTED (VALVE IN VALVE IN VALVE). THE PHYSICIAN IS UNSURE IF THE CENTRAL LEAK WAS CAUSED BY THROMBUS OR VALVE DEGENERATION. PER THE INSTRUCTIONS FOR USE, VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TAVR PROCEDURE. REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, LEAFLET THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. REGURGITATION MAY ALSO DEVELOP PROGRESSIVELY IF HOST FIBROTIC TISSUE, OR PANNUS, GROWS ONTO THE BIOPROSTHETIC VALVE. PANNUS, A CAUSE OF NONSTRUCTURAL DYSFUNCTION, MAY INTERFERE WITH FUNCTIONALITY OF THE DEVICE BY RESTRICTING THE LEAFLET MOTION LEADING TO ABNORMAL COAPTATION. 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 CAUSE OF THE WORSENING CENTRAL REGURGITATION CANNOT BE CONFIRMED BUT MAY BE RELATED TO PROGRESSION OF DISEASE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) EDWARDS AFFILIATE, 8 MONTH POST VALVE IN VALVE (26MM SAPIEN XT VALVE INSIDE A SURGICAL MOSAIC VALVE) DUE TO VALVE DEGENERATION IN THE MITRAL POSITION, THE SAPIEN XT VALVE IS DEGENERATED. THE PATIENT¿S PHYSICIAN IS CONSIDERING THE IMPLANT OF A THIRD VALVE OR OPEN HEART SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537807 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention