BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 10002365 · Received April 27, 2020

    Report

    Report Number
    2025587-2020-01434
    Event Type
    Injury
    Date Received
    April 27, 2020
    Date of Event
    March 20, 2020
    Report Date
    April 27, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: HIRJI S ET AL. MULTICENTER VALUATION OF QUALITY OF LIFE IN PATIENTS WITH PARADOXICAL LOW-FLOW, LOW-GRADIENT UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (PLO-FLOW TAVR STUDY). JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. MARCH 24, 2020. VOLUME 75, ISSUE 11 SUPPLEMENT 1: 1488. DOI: 10.1016/S0735-1097(20)32115-X. PUBLISHED ONLINE MARCH 20, 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 THE 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 THE PROGNOSTIC IMPACT OF TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH STAGE D3 AORTIC STENOSIS (PARADOXICAL LOW-FLOW, LOW-GRADIENT) COMPARED TO PATIENTS WITH STAGES D4 (NORMAL-FLOW, LOW-GRADIENT),D1 (HIGH-GRADIENT), OR D2 (CLASSICAL LOW-FLOW, LOW-GRADIENT). ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN JANUARY 2016 AND DECEMBER 2017. THE STUDY POPULATION INCLUDED 822 PATIENTS. AN UNIDENTIFIED PROPORTION OF THE PATIENT COHORT WERE IMPLANTED WITH MEDTRONIC EVOLUT R OR EVOLUT PRO TRANSCATHETER VALVES. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 16 OPERATIVE DEATHS OCCURRED. MEDTRONIC AND NON-MEDTRONIC TRANSCATHETER VALVES WERE USED IN THE STUDY AND NO FURTHER DETAILS ABOUT THE DEATHS WERE PROVIDED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: STROKE, UNSPECIFIED REQUIREMENT FOR INTENSIVE CARE UNIT STAY, AND MILD-MODERATE PARAVALVULAR LEAK. 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
    465681 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening