BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 6957621 · Received October 18, 2017

    Report

    Report Number
    2025587-2017-01865
    Event Type
    Injury
    Date Received
    October 18, 2017
    Date of Event
    May 11, 2015
    Report Date
    October 18, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: COLLAS, V. MD. MIDTERM CLINICAL OUTCOME FOLLOWING EDWARDS SAPIEN OR MEDTRONIC COREVALVE TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI): RESULTS OF THE BELGIAN TAVI REGISTRY. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS (2015) 86:528¿535 DOI 10.1002/CCD.25999 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING MIDTERM (3 YEAR) OUTCOMES AFTER THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. ALL DATA WERE COLLECTED FROM MULTI-CENTER REGISTRY BETWEEN 2007 AND 2012. THE STUDY POPULATION INCLUDED 861 PATIENTS, 401 OF WHICH WERE IMPLANTED WITH A COREVALVE AND 460 OF WHICH WERE IMPLANTED WITH A NON-MEDTRONIC BALLOON EXPANDABLE BIOPROSTHETIC AORTIC VALVE. THE STUDY POPULATION WAS PREDOMINANTLY FEMALE; MEAN AGE 83 YEARS. SERIAL NUMBERS NOT PROVIDED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: MYOCARDIAL INFARCTION (MI), CEREBRAL VASCULAR ACCIDENT (CVA), ELECTROCARDIOGRAM (ECG) CHANGES TREATED WITH THE IMPLANT OF A PERMANENT PACEMAKER, VALVE DISLODGEMENT AND VALVE-IN-VALVE PROCEDURE. BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO A MEDTRONIC PRODUCT. HOWEVER, AS MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND THE MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737211 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