BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7180459 · Received January 10, 2018

    Report

    Report Number
    2025587-2018-00115
    Event Type
    Injury
    Date Received
    January 10, 2018
    Date of Event
    August 21, 2017
    Report Date
    January 10, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SCHYMIK, S. MD ET AL. TRANSCATHETER AORTIC VALVE IMPLANTATION IN PATIENTS WITH A REDUCED LEFT VENTRICULAR EJECTION FRACTION: A SINGLE CENTRE EXPERIENCE IN 2000 PATIENTS (TAVIK REGISTRY). CLIN RES CARDIOL (2017) DEC;106(12):1018-1025 DOI 10.1007/S00392-017-1151-9 EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE . NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING OUTCOMES AFTER THE A TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH REDUCED LEFT VENTRICLE EJECTION FRACTION. ALL DATA WERE COLLECTED FROM SINGLE CENTERS REGISTRY BETWEEN 2008 AND 2015. THE STUDY POPULATION INCLUDED 2000 PATIENTS, 360 OF WHICH WERE IMPLANTED WITH A COREVALVE. SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: MYOCARDIAL INFARCTION (MI), CEREBRAL VASCULAR ACCIDENT (CVA), VASCULAR COMPLICATIONS, BLEEDING, AND PERMANENT PACEMAKER IMPLANT. BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO A MEDTRONIC PRODUCT. HOWEVER AS MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND THE MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23848 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention