BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 9369479 · Received November 25, 2019

    Report

    Report Number
    2025587-2019-03574
    Event Type
    Injury
    Date Received
    November 25, 2019
    Date of Event
    September 15, 2019
    Report Date
    November 25, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ANCONA, MARCO, MD. ET AL. IMPACT OF THE ASCENDING AORTA DILATION ON MID-TERM OUTCOME AFTER TRANSCATHETER AORTIC VALVE IMP LANTATION. JOURNAL OF INVASIVE CARDIOLOGY. 2019. 31(10):278-281. 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. [(B)(4)].

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING OUTCOMES OF PATIENTS WITH ASCENDING AORTIC DILATION AFTER THE IMPLANT OF A TRANSCATHETER AORTIC VALVE (TAV). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2008 AND JANUARY 2017. THE STUDY POPULATION INCLUDED 680 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 82 ± YEARS). PATIENTS WERE IMPLANTED WITH EITHER A BALLOON EXPANDABLE NON-MEDTRONIC TAV, A MECHANICAL-EXPANDABLE NON-MEDTRONIC TAV OR A MEDTRONIC COREVALVE OR EVOLUTR SELF-EXPANDING TAV. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: VASCULAR COMPLICATIONS, PERMANENT PACEMAKER IMPLANT, AND PARAVALVULAR LEAK (PVL). BASED ON THE AVAILABLE INFORMATION, A MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163109 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