BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 8613167 · Received May 15, 2019

    Report

    Report Number
    2025587-2019-01600
    Event Type
    Injury
    Date Received
    May 15, 2019
    Date of Event
    August 24, 2017
    Report Date
    May 15, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ELMARAEZY A ET AL. EFFICACY AND SAFETY OF TRANSCATHETER AORTIC VALVE REPLACEMENT IN AORTIC STENOSIS PATIENTS AT LOW TO MODERATE SURGICAL RISK: A COMPREHENSIVE META-ANALYSIS. BMC CARDIOVASC DISORD. 2017 AUG 24;17(1):234. DOI: 10.1186/S12872-017-0668-1. 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 META-ANALYSIS OF THE EFFICACY AND SAFETY OF TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH AORTIC STENOSIS WHO ARE AT LOW TO MODERATE SURGICAL RISK. ALL DATA WAS COLLECTED FROM A SYSTEMATIC SEARCH OF THE PUBMED, SCOPUS, WEB OF SCIENCE, EMBASE, AND CENTRAL DATABASES WITH 11 STUDIES (REPORTED IN 15 PUBLISHED ARTICLES) DEEMED ELIGIBLE FOR INCLUSION IN THE ANALYSIS. THE OVERALL STUDY POPULATION INCLUDED 20,056 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 79 YEARS), AN UNSPECIFIED NUMBER OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE BIOPROSTHETIC VALVES (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, MORTALITY RATES (IN-HOSPITAL, 30-DAY, 1-YEAR, 2-YEAR, 3-YEAR, AND ALL-CAUSE) 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: PERMANENT PACEMAKER IMPLANTATION, STROKE, MYOCARDIAL INFARCTION, PARAVALVULAR AORTIC RE GURGITATION, MAJOR/LIFE-THREATENING BLEEDING, AND VASCULAR ACCESS 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
    405536 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention