BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 7660510 · Received July 3, 2018

    Report

    Report Number
    2025587-2018-01677
    Event Type
    Injury
    Date Received
    July 3, 2018
    Date of Event
    April 17, 2018
    Report Date
    July 3, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: YU CW, TRENDS AND OUTCOMES OF TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) IN KOREA: THE RESULTS OF THE FIRST COHORT OF KOREAN TAVI REGISTRY. KOREAN CIRC J. 2018 MAY;48(5):382-394. DOI: 10.4070/KCJ.2018.0117. EPUB (B)(6) 2018. 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 TRENDS AND OUTCOMES OF TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) IN KOREA. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN JUNE 2015 AND JUNE 2017. THE STUDY POPULATION INCLUDED 576 PATIENTS (PREDOMINANTLY FEMALE; MEDIAN AGE 79 YEARS), 71 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE PROSTHESIS AND 167 PATIENTS WERE IMPLANTED WITH MEDTRONIC EVOLUT R. THE SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS IN-HOSPITAL, 30-DAY, ALL-CAUSE AND CARDIOVASCULAR MORTALITY OCCURRED DUE TO UNSPECIFIED CAUSES. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: CORONARY OBSTRUCTION, MYOCARDIAL INFARCTION, DISABLING STROKE, MAJOR BLEEDING, SECOND VALVE IMPLANTATION, PACEMAKER IMPLANTATION, AORTIC DISSECTION, RUPTURE OF AORTA, PERFORATION OF LEFT VENTRICLE, EMBOLISM, ACCESS SITE COMPLICATION, MODERATE TO SEVERE PARAVALVULAR LEAK (PVL) AND CARDIAC TAMPONADE. 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 PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500511 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention