BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7590066 · Received June 12, 2018

    Report

    Report Number
    2025587-2018-01442
    Event Type
    Injury
    Date Received
    June 12, 2018
    Date of Event
    April 13, 2018
    Report Date
    June 11, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: GREASON KL PREDICTORS OF 1-YEAR MORTALITY AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT J CARD SURG. 2018;33:243¿249 DOI 10 .1111/JOCS.13574 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. 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 PREDICTORS OF 1-YEAR MORTALITY AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN NOVEMBER 2008 THROUGH APRIL 2016. THE STUDY POPULATION INCLUDED 723 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 82 YEARS), OF WHICH 116 WERE IMPLANTED WITH MEDTRONIC COREVALVE PROSTHESIS AND 32 WERE IMPLANTED WITH MEDTRONIC EVOLUT R PROSTHESIS. THE SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS IN-HOSPITAL, 30-DAY AND 1-YEAR MORTALITY OCCURRED DUE TO UNSPECIFIED CAUSES. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION, STROKE, VASCULAR INJURY, CONVERSION TO SURGICAL AORTIC VALVE. BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO A MEDTRONIC PRODUCT. HOWEVER AS MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND THE MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435579 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention