BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VLV (26MM)

    MDR report key: 5217399 · Received November 11, 2015

    Report

    Report Number
    2015691-2015-03042
    Event Type
    Injury
    Date Received
    November 11, 2015
    Date of Event
    March 9, 2015
    Report Date
    October 15, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE 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.

    Description of Event or Problem · 1

    AS PER THE ARTICLE "FACTORS INFLUENCING LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION FOLLOWING A MITRAL VALVE-IN-VALVE OR VALVE-IN-RING PROCEDURE, PART 1", A 26MM SAPIEN XT VALVE WAS IMPLANTED WITHIN A MOSAIC MITRAL PROSTHESIS AND THE GRADIENT ACROSS THE LVOT WAS MEASURED TO BE 30MM. THE PATIENT WAS DISCHARGED ON 7 DAYS POST PROCEDURE, BUT PRESENTED WITHIN 6 WEEKS IN CCF. THE INVESTIGATIONS REVEALED AN INCREASE IN LVOT GRADIENT TO 60 MM. REDO OPEN SURGERY WAS UNDERTAKEN AND THE MITRAL SHV WAS REMOVED ALONG WITH THE SAPIEN XT VALVE. VISUALIZATION OF THE AORTA CONFIRMED SIGNIFICANT LVOT OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747294 EDWARDS SAPIEN XT TRANSCATHETER HEART VLV (26MM) AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention