BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 7180363 · Received January 10, 2018

    Report

    Report Number
    2025587-2018-00114
    Event Type
    Injury
    Date Received
    January 10, 2018
    Date of Event
    July 1, 2017
    Report Date
    January 10, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KLECZYNSKI, P. MD ET AL. PROGNOSTIC VALUE OF TRICUSPID REGURGITATION VELOCITY AND PROBABILITY OF PULMONARY HYPERTENSION IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION. INT J CARDIOVASC IMAGING (2017) DEC;33(12):1931-1938. DOI 10.1007/S105 54-017-1210-3. 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 TRICUSPID REGURGITATION AND PROBABILITY OF PULMONARY HYPERTENSION AFTER A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE STUDY POPULATION INCLUDED 148 PATIENTS, 29 OF WHICH WERE IMPLANTED WITH A COREVALVE OR AN EVOLUT R. SERIAL NUMBERS WERE NOT PROVIDED. THE STUDY POPULATION WAS PREDOMINANTLY FEMALE; MEAN AGE 82 YEARS. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: CEREBRAL VASCULAR ACCIDENT (CVA)/TRANSIENT ISCHEMIC ATTACK (TIA), ATRIAL FIBRILLATION (AFIB), MILD TO SEVERE AORTIC REGURGITATION, PERMANENT PACEMAKER IMPLANT, MYOCARDIAL INFARCTION (MI), AND BLOOD LOSS. 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
    23810 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention