BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE REVALVING SYSTEM

    MDR report key: 6662156 · Received June 22, 2017

    Report

    Report Number
    2025587-2017-01021
    Event Type
    Injury
    Date Received
    June 22, 2017
    Date of Event
    May 30, 2017
    Report Date
    June 9, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: S. YOON, ET AL. OUTCOMES IN TRANSCATHETER AORTIC VALVE REPLACEMENT FOR BICUSPID VERSUS TRICUSPID AORTIC VALVE STENOSIS. J A C C V O L . 6 9 , N O. 2 1 , 2 0 1 7. H T T P : / / D X . D O I . O R G / 1 0. 1 0 1 6 / J . J A C C . 2 0 1 7 . 0 3 . 0 1 7 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. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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 OUTCOMES IN TRANSCATHETER AORTIC VALVE REPLACEMENT FOR BICUSPID VERSUS TRICUSPID AORTIC VALVE STENOSIS. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS. THE STUDY POPULATION INCLUDED 1092 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 77 YEARS), 336 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE AND 39 EVOLUTR (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS 139 ALL CAUSE DEATHS OCCURRED, 13 DEATHS WERE NOTED AS PROCEDURE RELATED. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: STROKE, BLEEDING, MAJOR VASCULAR COMPLICATION, ACUTE KIDNEY INJURY, CONVERSION TO SURGERY, CORONARY OBSTRUCTION, AORTIC ROOT INJURY, IMPLANTATION OF 2 VALVES, PARAVALVULAR LEAK, NEW PERMANENT PACEMAKER, BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440714 COREVALVE REVALVING SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R