BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7156419 · Received January 1, 2018

    Report

    Report Number
    2025587-2018-02589
    Event Type
    Injury
    Date Received
    January 1, 2018
    Date of Event
    November 1, 2016
    Report Date
    January 1, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: N WANG. TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) VERSUS SUTURELESS AORTIC VALVE REPLACEMENT (SUAVR) FOR AORTIC STENOSIS: A SYSTEMATIC REVIEW AND META-ANALYSIS OF MATCHED STUDIES. J THORAC DIS. 2016 NOV; 8(11): 3283¿3293. DOI: 10.21037/JTD.2016.11.100 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 LITERATURE META-ANALYSIS REGARDING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) VERSUS SUTURELESS AORTIC VALVE REPLACEMENT. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS. THE STUDY POPULATION INCLUDED 741 PATIENTS, AN UNSPECIFIED NUMBER OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE AND 3F ENABLE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS PERIOPERATIVE, ONE AND TWO-YEAR MORTALITY OCCURRED DUE TO UNSPECIFIED CAUSES. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: BLEEDING REQUIRING RE-OPERATION, PERMANENT PACEMAKER IMPLANT, STROKE, AND MODERATE TO SEVERE PARAVALVULAR LEAK (PVL). 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
    55 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention