BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 9498002 · Received December 19, 2019

    Report

    Report Number
    2025587-2019-03833
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    September 9, 2019
    Report Date
    December 19, 2019
    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: KALINCZUK L ET AL. EFFECT ON MORTALITY OF SYSTEMIC THROMBOINFLAMMATORY RESPONSE AFTER TRANSCATHETER AORTIC VALVE IMPLANTAT ION. AM J CARDIOL. 2019 DEC 1;124(11):1741-1747. DOI: 10.1016/J.AMJCARD.2019.08.036. EPUB 2019 SEP 9. ATTACHED SUPPLEMENTARY DATA DOCUMENT. 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. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING AN ANALYSIS OF THE PROGNOSTIC VALUE OF EARLY PLATELET AND WHITE BLOOD CELL COUNT CHANGES IN PATIENTS WHO UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN AUGUST 2009 AND OCTOBER 2017. THE STUDY POPULATION INCLUDED 432 PATIENTS AND WAS PREDOMINANTLY FEMALE WITH A MEAN AGE OF 82 YEARS AND A MEAN WEIGHT OF 73 KG. OF THOSE, 243 WERE IMPLANTED WITH MEDTRONIC TRANSCATHETER AORTIC VALVES: COREVALVE (136) AND EVOLUT R OR EVOLUT PRO (107). NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, THE 30-DAY AND 1-YEAR MORTALITY RATES WERE 3.0% (13 PATIENTS) AND 13.4% (58 PATIENTS), RESPECTIVELY. NO OTHER DETAILS WERE REPORTED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEW PERMANENT PACEMAKER IMPLANTATION, STROKE, VALVE-IN-VALVE IMPLANTATION, INFECTION, FEVER, MODERATE PARAVALVULAR LEAK, BLEEDING (LIFE-THREATENING, DISABLING, OR MAJOR), AND MAJOR VASCULAR COMPLICATIONS. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293184 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