BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 7567750 · Received June 4, 2018

    Report

    Report Number
    2025587-2018-01373
    Event Type
    Injury
    Date Received
    June 4, 2018
    Date of Event
    March 8, 2018
    Report Date
    June 4, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: PETRONIO ET AL. ASSOCIATIONS BETWEEN VALVE TYPE AND OUTCOMES IN WOMEN UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT: RESULTS FROM THE WIN-TAVI REGISTRY. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. MARCH 2018, VOLUME 71, ISSUE 11 SUPPLEMENT. DOI: 10.1016/S0735-1097(18)31960-0. 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. 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 COMPARATIVE OUTCOMES OF WOMEN RECEIVING BALLOON-EXPANDABLE (BEV) OR SELF-EXPANDING VALVES (SEV) IN CONTEMPORARY TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM AN ALL-FEMALE REGISTRY FROM MULTIPLE CENTERS. THE STUDY POPULATION INCLUDED 869 PATIENTS (ALL FEMALE; MEAN AGE NOT PROVIDED), 461 OF WHICH WERE IMPLANTED WITH A MEDTRONIC COREVALVE OR EVOLUT R BIOPROSTHETIC VALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, DEATH EVENTS WERE NOT DIRECTLY IDENTIFIED BUT MAY HAVE OCCURRED AS DEFINED BY THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC) 2 CRITERIA. BASED ON THE AVAILABLE INFORMATION, NONE OF THESE POTENTIAL DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: POST TAVR AORTIC INSUFFICIENCY GRADE 2 OR 3, BLEEDING, MAJOR VASCULAR COMPLICATIONS, AND NEW PACEMAKER IMPLANTATION. OTHER ADVERSE EVENTS WERE NOT DIRECTLY IDENTIFIED BUT MAY HAVE OCCURRED AS DEFINED BY THE VARC 2 CRITERIA SUCH AS STROKE, MYOCARDIAL INFARCTION (MI), OR WORSENING CONGESTIVE HEART FAILURE. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409458 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention