BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 8885829 · Received August 12, 2019

    Report

    Report Number
    2025587-2019-02550
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    May 3, 2019
    Report Date
    August 12, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SZEKELY Y ET AL. RED BLOOD CELL DISTRIBUTION WIDTH AS A PROGNOSTIC FACTOR IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION. J CARDIOL. 2019 SEP;74(3):212-216. DOI: 10.1016/J.JJCC.2019.04.005. EPUB 2019 MAY 3. 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. (B)(4). 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 AN EVALUATION OF THE LONG-TERM PROGNOSTIC VALUE OF BASELINE RED BLOOD CELL DISTRIBUTION WIDTH IN PATIENTS WHO UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION. ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER. THE STUDY POPULATION INCLUDED 1,029 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 83 YEARS), 662 WERE IMPLANTED WITH MEDTRONIC COREVALVE (470) OR EVOLUT R (192) BIOPROSTHETIC VALVES. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, THE IN-HOSPITAL, 30-DAY, 1-YEAR AND 5-YEAR MORTALITY RATES WERE DISCUSSED. HOWEVER, MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION, NEW-ONSET ATRIAL FIBRILLATION OR FLUTTER, STROKE, TRANSIENT ISCHEMIC ATTACK, INFECTION, MODERATE-SEVERE PARAVALVULAR LEAK, CONVERSION TO OPEN SURGERY, CORONARY OBSTRUCTION, MITRAL VALVE DAMAGE, TAMPONADE, VENTRICULAR SEPTAL PERFORATION, VALVE MIGRATION/EMBOLIZATION, MAJOR VASCULAR COMPLICATIONS, AND MAJOR BLEEDING. 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
    676699 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention