BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 6962527 · Received October 19, 2017

    Report

    Report Number
    2025587-2017-01877
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    October 11, 2016
    Report Date
    October 19, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MARTINE GILARD. LATE OUTCOMES OF TRANSCATHETER AORTIC VALVE REPLACEMENT IN HIGH-RISK PATIENTS: THE FRANCE-2 REGISTRY. J AM COLL CARDIOL. 2016 OCT 11;68(15):1637-1647. DOI: 10.1016/J.JACC.2016.07.747 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 LATE OUTCOMES OF TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN 2010 AND 2012. THE STUDY POPULATION INCLUDED 4,201 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 83 YEARS), 1,413 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: PERIPROSTHETIC AORTIC REGURGITATION, PERMANENT PACEMAKER IMPLANT, STROKE, MYOCARDIAL INFARCTION, ENDOCARDITIS, VASCULAR COMPLICATIONS AND BLEEDING. 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
    740240 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention