BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 10084241 · Received May 22, 2020

    Report

    Report Number
    2025587-2020-01700
    Event Type
    Injury
    Date Received
    May 22, 2020
    Date of Event
    May 1, 2020
    Report Date
    May 22, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KOOLSTRA NHM ET AL. RANDOMISED COMPARISON OF A BALLOON-EXPANDABLE AND SELF-EXPANDABLE VALVE WITH QUANTITATIVE ASSESSMENT OF AORTIC REGURGITATION USING MAGNETIC RESONANCE IMAGING. NETHERLANDS HEART JOURNAL. 2020; 28:253-265. DOI: 10.1007/S12471-020-01414-0 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 QUANTITATIVE ASSESSMENT OF AORTIC REGURGITATION FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT USING MAGNETIC RESONANCE IMAGING (MRI). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2014 AND MAY 2016. THE STUDY POPULATION INCLUDED 56 PATIENTS (EQUAL MALE/FEMALE DISTRIBUTION, MEAN AGE 79 YEARS), 27 OF WHICH WERE IMPLANTED WITH A MEDTRONIC COREVALVE TRANSCATHETER VALVE (NO SERIAL NUMBERS PROVIDED). AMONG ALL MEDTRONIC COREVALVE PATIENTS, ADVERSE EVENTS INCLUDED: STROKE, PACEMAKER IMPLANTATION, MAJOR BLEEDING, MAJOR VASCULAR COMPLICATION, VALVE MALPOSITIONING, VALVE-IN-VALVE IMPLANTATION, MODERATE PARAVALVULAR LEAK. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547565 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