BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 6938633 · Received October 10, 2017

    Report

    Report Number
    2025587-2017-01806
    Event Type
    Injury
    Date Received
    October 10, 2017
    Date of Event
    August 22, 2016
    Report Date
    September 28, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ALTISENT, O. MD. WARFARIN AND ANTIPLATELET THERAPY VERSUS WARFARIN ALONE FOR TREATING PATIENTS WITH ATRIAL FIBRILLATION UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT. JACC CARDIOVASCULAR INTERVENTIONS; (2016); 9(16):1706-17. 10.1016/J.JCIN.2016.06.025 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).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING THE RISK OF ISCHEMIC EVENTS AND BLEEDING EPISODES ASSOCIATED WITH DIFFERING ANTITHROMBOTIC STRATEGIES IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH CONCOMITANT ATRIAL FIBRILLATION (AF). ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN 2007 AND 2015. THE STUDY POPULATION INCLUDED 621 PATIENTS, WHICH WERE IMPLANTED WITH EITHER A COREVALVE OR A NON-MEDTRONIC BALLOON EXPANDABLE TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. SERIAL NUMBERS WERE NOT PROVIDED. THE STUDY POPULATION WAS PREDOMINANTLY FEMALE; MEAN AGE 82 YEARS. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: CEREBROVASCULAR ACCIDENT, MYOCARDIAL INFARCT, VALVE-IN-VALVE, BLOOD LOSS, VASCULAR COMPLICATIONS, AND ELECTROCARDIOGRAM (ECG) CHANGES TREATED WITH THE IMPLANT OF A PERMANENT PACEMAKER. BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO 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
    716197 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention