BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 8744470 · Received June 28, 2019

    Report

    Report Number
    2025587-2019-02083
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    February 5, 2019
    Report Date
    June 28, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: WAGNER G ET AL. COMPARISON OF TRANSCATHETER AORTIC VALVE IMPLANTATION WITH OTHER APPROACHES TO TREAT AORTIC VALVE STENOSIS: A SYSTEMATIC REVIEW AND META-ANALYSIS. SYST REV. 2019 FEB 5;8(1):44. DOI: 10.1186/S13643-019-0954-3. ATTACHED ADDITIONAL FILE 4 (PATIENT CHARACTERISTICS AND OUTCOMES). 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. (B)(4). 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 A COMPARISON OF THE BENEFITS AND TRIBULATIONS OF TRANSCATHETER AORTIC VALVE IMPLANTATION, SURGICAL AORTIC VALVE REPLACEMENT, MEDICAL THERAPY, AND BALLOON AORTIC VALVULOPLASTY. ALL DATA WERE COLLECTED FROM A META-ANALYSIS REVIEW OF 19 STUDIES (6 RANDOMIZED CONTROLLED TRIALS AND 13 OBSERVATIONAL STUDIES) PUBLISHED BETWEEN 2002 AND 2017. THE OVERALL STUDY POPULATION INCLUDED 12,238 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 74 YEARS), AN UNSPECIFIED NUMBER OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE OR EVOLUT R BIOPROSTHETIC VALVES (NO SERIAL NUMBERS PROVIDED). MORTALITY RATES FOR 30-DAY, ONE-YEAR, AND ALL-CAUSE DEATHS WERE DISCUSSED. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEW PERMANENT PACEMAKER IMPLANTATION, MODERATE-SEVERE PARAVALVULAR AORTIC REGURGITATION, TRANSIENT ISCHEMIC ATTACK, STROKE, MYOCARDIAL INFARCTION, MAJOR BLEEDING, 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
    538877 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention