BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 7188719 · Received January 14, 2018

    Report

    Report Number
    2025587-2018-00165
    Event Type
    Injury
    Date Received
    January 14, 2018
    Date of Event
    October 1, 2017
    Report Date
    January 14, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: IMPACT OF AN ELECTROPHYSIOLOGY STUDY GUIDED PPM IMPLANTATION STRATEGY AFTER TAVR   CITATION: JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY OCT 2017, 70 (18 SUPPLEMENT) B231; DOI: 10.1016/J.JACC.2017.09.735   AUTHORS: ROGERS T ET AL. EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING THE IMPACT OF AN ELECTROPHYSIOLOGY (EP) STUDY GUIDED PERMANENT PACEMAKER IMPLANTATION STRATEGY AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2013 AND 2016. THE STUDY POPULATION INCLUDED 257 PATIENTS, AN UNSPECIFIED NUMBER OF WHICH WERE IMPLANTED WITH MEDTRONIC EVOLUTR (SERIAL NUMBERS NOT PROVIDED).   AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A POSSIBLE CORRELATION COULD BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT.   NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32240 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