BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 6940340 · Received October 11, 2017

    Report

    Report Number
    2025587-2017-01812
    Event Type
    Injury
    Date Received
    October 11, 2017
    Date of Event
    March 13, 2015
    Report Date
    September 21, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: AVERSA, E. MD. NEW CONDUCTION DISTURBANCES AND PACEMAKER INDICATIONS AFTER COREVALVE® TRANSCATHETER AORTIC VALVE REPLACEMENT. INCIDENCE AND FOLLOW UP IN A SINGLE CENTER EXPERIENCE. ARCHIVOS DE CARDIOLOGIA DE MEXICO; (2015) 85(4):278-83. DOI: 10.1016/J.A CMX.2014.12.001 EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING THE INCIDENCE OF NEW CONDUCTION DISTURBANCES AFTER THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2009 AND 2012. THE STUDY POPULATION INCLUDED 32 PATIENTS AND WAS PREDOMINANTLY MALE; MEAN AGE 80 YEARS. ALL PATIENTS WERE IMPLANTED WITH A COREVALVE TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: LEFT BUNDLE BRANCH BLOCK (LBBB), RIGHT BUNDLE BRANCH BLOCK (RBBB), PROLONGATED QRS SEGMENT, COMPLETE HEART BLOCK (CHB), PERMANENT PACEMAKER AND HIGH AND/OR LOW IMPLANT POSITIONS NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720044 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention