BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 9365987 · Received November 22, 2019

    Report

    Report Number
    2025587-2019-03572
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    September 28, 2017
    Report Date
    November 22, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: HOSOBA S. 'MINIMALIST' TRANS-SUBCLAVIAN TAVR WITH COREVALVE EVOLUT R. GENERAL THORACIC AND CARDIOVASCULAR SURGERY. 2017 65 (SUPPL):933-933. PRESENTED AT THE JAPAN THORACIC SURGERY SOCIETY ON SEPTEMBER 28, 2017. 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 TRANS-SUBCLAVIAN VERSUS TRANSFEMORAL APPROACH FOR TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN DECEMBER 2016 TO MARCH 2017. THE STUDY POPULATION INCLUDED 9 PATIENTS, ALL OF WHICH WERE IMPLANTED WITH A MEDTRONIC EVOLUT R BIOPROSTHETIC VALVE (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: STROKE, MODERATE AORTIC REGURGITATION, AND VASCULAR COMPLICATIONS WITH AN INTENSIVE CARE UNIT (ICU) MEDIAN STAY TIME OF ONE DAY. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157438 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L