BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 8672296 · Received June 5, 2019

    Report

    Report Number
    2025587-2019-01829
    Event Type
    Injury
    Date Received
    June 5, 2019
    Date of Event
    March 28, 2019
    Report Date
    June 5, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KAHRAMAN AY N. IMPACT OF AGE ON LONG TERM SURVIVAL FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION. J GERIATR CARDIOL. 2019 MAR; 16 (3): 265-271. DOI: 10.11909/J.ISSN.1671-5411.2019.03.003. EPUB 2019 MAR 28. 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 LONG-TERM SURVIVAL FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION IN AN OCTOGENARIAN POPULATION VERSUS A YOUNGER POPULATION. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN 2012 AND 2017. THE STUDY POPULATION INCLUDED 274 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE OF 78 YEARS), 91 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE BIOPROSTHETIC VALVES (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, 138 DEATHS OCCURRED DURING THE 5-YEAR FOLLOW-UP PERIOD DUE TO: ALL-CAUSES, CARDIOVASCULAR CAUSES, AND NON-CARDIOVASCULAR CAUSES. 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: CONVERSION TO SURGICAL AORTIC VALVE REPLACEMENT, CORONARY OBSTRUCTION, MILD-MODERATE-SEVERE PARAVALVULAR LEAK, MAJOR VASCULAR COMPLICATIONS, MAJOR/LIFE-THREATENING BLEEDING, NEW-ONSET ATRIAL FIBRILLATION, STROKE, AND PERMANENT PACEMAKER IMPLANTATION. 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
    466288 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention