BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 7368622 · Received March 24, 2018

    Report

    Report Number
    2025587-2018-00689
    Event Type
    Injury
    Date Received
    March 24, 2018
    Date of Event
    December 6, 2017
    Report Date
    March 24, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: OKITSU K ET AL. CHOICE OF DESFLURANE OR PROPOFOL FOR THE MAINTENANCE OF GENERAL ANESTHESIA DOES NOT AFFECT THE RISK OF PERIPROCEDURAL MYOCARDIAL DAMAGE IN PATIENTS UNDERGOING TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION. J ANESTH. 2018 FEB;32(1):82-89. DOI: 10.1007/S00540-017-2435-Y. 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. 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 PERIPROCEDURAL MYOCARDIAL DAMAGE IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) RECEIVING DESFLURANE OR PROPOFOL ANESTHESIA. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2015 AND 2017. THE STUDY POPULATION INCLUDED 140 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 84 YEARS), 31 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE AND 18 OF WHICH WERE IMPLANTED WITH MEDTRONIC EVOLUTR (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: BLEEDING AND VASCULAR COMPLICATIONS, ATRIAL FIBRILLATION, PERMANENT PACEMAKER IMPLANT, AND ELEVATED CARDIAC ENZYMES. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211494 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention