BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 8419131 · Received March 13, 2019

    Report

    Report Number
    2025587-2019-00922
    Event Type
    Injury
    Date Received
    March 13, 2019
    Date of Event
    February 14, 2019
    Report Date
    March 13, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: HUCHET ET AL. A COMPARATIVE PROFITABILITY ANALYSIS OF TRANSCATHETER VERSUS SURGICAL AORTIC VALVE REPLACEMENT IN A HIGH-VOLUME FRENCH HOSPITAL. HEALTH ECON REV. 2019 FEB 14;9(1):6. DOI: 10.1186/S13561-019-0223-0. 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 ANALYSIS OF TRANSCATHETER VERSUS SURGICAL AORTIC VALVE REPLACEMENT. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN SEPTEMBER 2014 AND DECEMBER 2015. THE STUDY POPULATION INCLUDED 341 SURGICAL AORTIC VALVE REPLACEMENT (SAVR) PATIENTS (PREDOMINANTLY MALE, MEAN AGE 74.5 YEARS) AND 238 TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 81.8 YEARS). FOR THE 238 TAVR PATIENTS, 49 WERE IMPLANTED WITH A MEDTRONIC EVOLUT R BIOPROSTHETIC VALVES. NO SERIAL NUMBERS WERE PROVIDED. AMONG THE TAVR PATIENTS, ADVERSE EVENTS INCLUDED: SEVERE AORTIC REGURGITATION, DISABLING STROKE, MYOCARDIAL INFARCTION, MAJOR VASCULAR COMPLICATIONS, PERMANENT PACEMAKER IMPLANTATION, AND ACUTE KIDNEY INJURY. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208636 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