BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 7661742 · Received July 4, 2018

    Report

    Report Number
    2025587-2018-01682
    Event Type
    Injury
    Date Received
    July 4, 2018
    Date of Event
    June 30, 2017
    Report Date
    July 3, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BAVRY AA COMPARISON OF DIFFERENT INVASIVE HEMODYNAMIC MEASUREMENTS AS A PREDICTION TOOL FOR MORTALITY AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT IN MEN: A RETROSPECTIVE OBSERVATIONAL STUDY. CARDIOL THER. 2017 DEC;6(2):251-259. DOI: 10.1007/S40119-017-0095-5. EPUB 2017 JUN 30. 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 COMPARISON OF DIFFERENT INVASIVE HEMODYNAMIC MEASUREMENTS AS A PREDICTION TOOL FOR MORTALITY AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT IN MEN. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN SEPTEMBER 2013 AND NOVEMBER 2016. THE STUDY POPULATION INCLUDED 151 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 77 YEARS), NINE OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE PROSTHESIS AND FOUR PATIENTS WERE IMPLANTED WITH MEDTRONIC EVOLUT R PROSTHESIS. THE SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS 30-DAY MORTALITY OCCURRED DUE TO UNSPECIFIED CAUSES. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: MODERATE-SEVERE AORTIC REGURGITATION (AR),VALVE-IN-VALVE, LEFT BUNDLE BRANCH BLOCK (LBBB) AND PERMANENT PACEMAKER IMPLANTATION. BASED ON THE AVAILABLE INFORMATION, A DIRECT CORRELATION WAS LIKELY BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. HOWEVER AS MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND THE MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504261 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention