BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 6964551 · Received October 20, 2017

    Report

    Report Number
    2025587-2017-01889
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    January 13, 2015
    Report Date
    October 20, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: S. DE BRITO JR, F. MD. OUTCOMES AND PREDICTORS OF MORTALITY AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION: RESULTS OF THE BRAZILIAN REGISTRY. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS (2015) 85:E153¿E162 DOI 10.1002/CCD.25778 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. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING OUTCOMES AND PREDICTORS OF MORTALITY AFTER THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. ALL DATA WERE COLLECTED FROM A MULTI-CENTER REGISTRY BETWEEN 2008 AND 2013. THE STUDY POPULATION INCLUDED 418 PATIENTS, WHICH WERE IMPLANTED WITH EITHER A COREVALVE OR A NON-MEDTRONIC BALLOON EXPANDABLE TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. THE STUDY POPULATION WAS PREDOMINANTLY FEMALE; MEAN AGE 82.5 YEARS. SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: VALVE DISLODGEMENT OR MALPOSITIONING, DEVICE UNDER EXPANSION, INCREASED GRADIENT MEASUREMENTS, MODERATE TO SEVERE PARAVALVULAR LEAK (PVL), CORONARY OBSTRUCTION, IMPLANTATION OF MULTIPLE VALVES, MITRAL VALVE DAMAGE/DYSFUNCTION, ANNULUS RUPTURE, CARDIAC TAMPONADE, LEFT VENTRICLE PERFORATION, MYOCARDIAL INFARCTION (MI), ELECTROCARDIOGRAM (ECG) CHANGES TREATED W PERMANENT PACEMAKER IMPLANT, ENDOCARDITIS TREATED WITH ANTIBIOTICS AND CONVERSION TO OPEN SURGERY. 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
    745054 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention