BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7038059 · Received November 16, 2017

    Report

    Report Number
    2025587-2017-02148
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    February 1, 2016
    Report Date
    November 16, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KOSTOPOULOU A. MANAGEMENT OF CORONARY ARTERY DISEASE AND CONDUCTION ABNORMALITIES IN TRANSCATHETER AORTIC VALVE IMPLANTATION. CURR. TREAT OPTIONS CARDIOVASC MED. 2016 FEB;18(2):9 DOI: 10.1007/S11936-015-0432-8 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 THE MANAGEMENT OF CORONARY ARTERY DISEASE AND CONDUCTION ABNORMALITIES IN TRANSCATHETER AORTIC VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM MULTIPLE STUDIES. THE OVERALL STUDY POPULATION INCLUDED 24,584 PATIENTS, OF WHOM, AT LEAST 4,801 WERE IMPLANTED WITH MEDTRONIC COREVALVE® (SERIAL NUMBERS AND SPECIFIC IMPLANT RATES NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: STROKE, CONDUCTION DISTURBANCES, PERMANENT PACEMAKER IMPLANTATION, CONVERSION TO OPEN HEART SURGERY, AND VASCULAR COMPLICATIONS. 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
    818662 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention