BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7043967 · Received November 18, 2017

    Report

    Report Number
    2025587-2017-02181
    Event Type
    Injury
    Date Received
    November 18, 2017
    Date of Event
    June 12, 2015
    Report Date
    November 18, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LINDSAY A.C. CLINICAL AND ECONOMIC CONSEQUENCES OF NON-CARDIAC INCIDENTAL FINDINGS DETECTED ON CARDIOVASCULAR COMPUTED TOMOGRAPHY PERFORMED PRIOR TO TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). INT J CARDIOVASC IMAGING. 2015 OCT;31(7):1435-46. DOI: 10 .1007/S10554-015-0685-Z. 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING CLINICAL AND ECONOMIC CONSEQUENCES OF NON-CARDIAC INCIDENTAL FINDINGS DETECTED ON CARDIOVASCULAR COMPUTED TOMOGRAPHY PERFORMED PRIOR TO TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2007 AND 2011. THE STUDY POPULATION INCLUDED 380 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 79 YEARS; 219 RECEIVED TAVI), AN UNSPECIFIED NUMBER OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE® (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS 46 DEATHS OCCURRED. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: NEW CONDUCTION ABNORMALITIES, AORTIC REGURGITATION, AND EMERGENCY VALVE-IN-VALVE. 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
    823272 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention