BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7027323 · Received November 14, 2017

    Report

    Report Number
    2025587-2017-02105
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    May 1, 2015
    Report Date
    November 14, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: FRERKER C. EXPANSION OF THE INDICATION OF TRANSCATHETER AORTIC VALVE IMPLANTATION--FEASIBILITY AND OUTCOME IN "OFF-LABEL" PATIENTS COMPARED WITH "ON-LABEL" PATIENTS. J INVASIVE CARDIOL. MAY 2015; 27(5):229-36 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 REGARDING OUTCOMES OF PERFORMING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2008 AND 2012. THE STUDY POPULATION INCLUDED 591 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 80 YEARS), 343 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: VALVE EMBOLIZATION, MODERATE AORTIC REGURGITATION, PARAVALVULAR LEAK (PVL), VALVE-IN-VALVE, PERMANENT PACEMAKER IMPLANT, STROKE, CARDIOPULMONARY BYPASS (CPB), 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
    808249 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention