BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 7071068 · Received November 30, 2017

    Report

    Report Number
    2025587-2017-02299
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    November 3, 2017
    Report Date
    November 30, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JAIN, R. ET AL. TRANSTHORACIC ECHOCARDIOGRAPHY IS ADEQUATE FOR INTRAPROCEDURAL GUIDANCE OF TRANSCATHETER AORTIC VALVE IMPLANTATION. ECHO RSEARCH AND PRACTICE. (2017) DEC;4(4):63-72 DOI 10.1530/ERP-17-0050 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 THE USE OF TRANSTHORACIC ECHOCARDIOGRAM (TTE) DURING THE IMPLANT OF T TRANSCATHETER AORTIC VALVE REPLACEMENT. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2015 AND 2016. THE STUDY POPULATION INCLUDED 278 PATIENTS, 258 OF WHICH WERE IMPLANTED WITH AN EVOLUTR AND 17 OF WHICH WERE IMPLANTED WITH A COREVALVE. THE REMAINING PATIENTS WERE IMPLANTED WITH A NON-MEDTRONIC DEVICE. SERIAL NUMBERS WERE NOT PROVIDED. THE STUDY POPULATION WAS PREDOMINANTLY FEMALE; MEAN AGE 82.1 YEARS. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: CEREBRAL VASCULAR ACCIDENT (CVA), TRACE TO MODERATE PARAVALVULAR LEAK (PVL), BALLOON AORTIC VALVULOPLASTY (BAV) DUE TO PARAVALVULAR LEAK OR STENT UNDER EXPANSION, VALVE-IN-VALVE DUE TO DEEP IMPLANT AND/OR REGURGITATION, LEFT VENTRICULAR OUTFLOW TRACT (LVOT) OR MIDVENTRICULAR OBSTRUCTION, RIGHT CORONARY ARTERY OBSTRUCTION AND PERICARDIAL EFFUSION. 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
    849178 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