BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 7564169 · Received June 3, 2018

    Report

    Report Number
    2025587-2018-01360
    Event Type
    Injury
    Date Received
    June 3, 2018
    Date of Event
    March 8, 2018
    Report Date
    June 3, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SHAH A. CLINICAL OUTCOMES FOR MEDTRONIC EVOLUT-R VERSUS CORE VALVE TRANSCATHETER AORTIC VALVE IMPLANTATION JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY MAR; 71(11): SUPPL A1134 EPUB 2018 MAR 8 DOI 10.1016/S0735-1097(18)31675-9 EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA POSTER PRESENTATION ON META-ANALYSIS REGARDING CLINICAL OUTCOMES FOR MEDTRONIC EVOLUT-R VERSUS CORE VALVE TRANSCATHETER AORTIC VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM MULTIPLE STUDIES UNTIL FEBRUARY 2017. THE OVERALL STUDY POPULATION INCLUDED 9,737 PATIENTS, OF WHICH, 6,820 PATIENTS WERE IMPLANTED WITH MEDTRONIC COREVALVE® AND 2,917 PATIENTS WERE IMPLANTED WITH MEDTRONIC EVOLUT R PROSTHESIS (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: CEREBRAL VASCULAR ACCIDENT (CVA), PERMANENT PACEMAKER AND VASCULAR COMPLICATIONS. BASED ON THE AVAILABLE INFORMATION, A DIRECT CORRELATION WAS LIKELY BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406322 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention