BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 10094349 · Received May 27, 2020

    Report

    Report Number
    2025587-2020-01722
    Event Type
    Injury
    Date Received
    May 27, 2020
    Date of Event
    April 6, 2020
    Report Date
    May 27, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LATIB A ET AL. FIRST-IN-MAN STUDY EVALUATING THE EMBLOK EMBOLIC PROTECTION SYSTEM DURING TRANSCATHETER AORTIC VALVE REPLACEMENT. JACC CARDIOVASC INTERV. 2020 APR 13;13(7):860-868. DOI: 10.1016/J.JCIN.2019.11.017. AVAILABLE ONLINE (B)(6) 2020. 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 THROUGH A LITERATURE ARTICLE REGARDING AN EVALUATION OF THE FEASIBILITY OF COMPLETE CEREBRAL PROTECTION DURING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A NON-MEDTRONIC EMBOLIC PROTECTION DEVICE. ALL DATA WERE COLLECTED FROM TWO CENTERS BETWEEN MARCH 2017 AND FEBRUARY 2018. THE STUDY POPULATION INCLUDED 20 PATIENTS AND WAS PREDOMINANTLY MALE WITH A MEAN AGE OF 82 YEARS. OF THOSE, 12 WERE IMPLANTED WITH MEDTRONIC TRANSCATHETER VALVES: EVOLUT R (11) AND EVOLUT PRO (1). NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION DUE TO UNSPECIFIED CONDUCTION DISTURBANCES; NEW ONSET ATRIAL FIBRILLATION THAT WAS TREATED WITH ANTICOAGULANT MEDICATION; NEW ISCHEMIC BRAIN LESIONS (OBSERVED ON DIFFUSION-WEIGHTED MAGNETIC RESONANCE IMAGING WITHIN 2 TO 5 DAYS AFTER TAVR); AND UNSPECIFIED DAMAGE AT THE LEFT COMMON FEMORAL ARTERY ACCESS SITE THAT REQUIRED COVERED STENT 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
    557194 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention