BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 9412284 · Received December 4, 2019

    Report

    Report Number
    2015691-2019-04472
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    November 14, 2019
    Report Date
    November 14, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    VALVE IN VALVE IS PERFORMED AS AN INTERVENTION FOR SEVERE OR CLINICALLY SIGNIFICANT PVL, CENTRAL LEAK, OR VALVES DEPLOYED TOO AORTIC/TOO VENTRICULAR. THIS INTERVENTION IS PERFORMED TO TREAT SERIOUS INJURY AND/OR PREVENT PERMANENT IMPAIRMENT. DUE TO THE LIMITED INFORMATION AVAILABLE, THE REASON FOR THIS VALVE IN VALVE PROCEDURE CANNOT BE DETERMINED. IT IS POSSIBLE THAT, IN ADDITION TO THE PROCEDURE ITSELF, UNKNOWN PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. AT THE TIME OF THIS REPORT, THERE IS NO INDICATION OR ALLEGATION THAT A PRODUCT DEFICIENCY OR DEVICE MALFUNCTION 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. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN AND IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    AS REPORTED BY AN EDWARDS LIFESCIENCES AFFILIATE IN THE UNITED KINGDOM, A 23 MM SAPIEN 3 XT VALVE WAS INVOLVED IN A VALVE IN VALVE (VIV) PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205404 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention