BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 9565291 · Received January 8, 2020

    Report

    Report Number
    2025587-2020-00083
    Event Type
    Injury
    Date Received
    January 8, 2020
    Date of Event
    November 1, 2019
    Report Date
    January 8, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: IIZUKA, T. MD. ET AL. CEREBRAL INFARCTION AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION IN JAPAN: RETROSPECTIVE ANALYSIS AT A SINGLE HIGH-VOLUME CENTER. JOURNAL OF STROKE AND CEREBROVASCULAR DISEASES. 2019; 28(12):104455. DOI:10.1016/J.JSTROKECEREBROVASDIS.2019.104455. 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 RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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 THE INCIDENCE OF CEREBRAL VASCULAR ACCIDENTS (CVA) AFTER THE IMPLANT OF A TRANSCATHETER AORTIC VALVE (TAV). ALL DATA WERE COLLECTED RETROSPECTIVELY FROM A SINGLE CENTER BETWEEN OCTOBER 2013 AND OCTOBER 2016. THE STUDY POPULATION INCLUDED 308 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 84 YEARS). PATIENTS WERE IMPLANT WITH EITHER A NON-MEDTRONIC BALLOON-EXPANDABLE TAV, A MEDTRONIC COREVALVE OR AN EVOLUTR TAV. NO SERIAL NUMBERS PROVIDED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: SYMPTOMATIC CEREBRAL VASCULAR ACCIDENT WITHIN SEVEN DAYS AFTER TAV IMPLANT. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27592 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening| S