BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE REVALVING SYSTEM

    MDR report key: 6609842 · Received June 2, 2017

    Report

    Report Number
    2025587-2017-00908
    Event Type
    Injury
    Date Received
    June 2, 2017
    Date of Event
    November 1, 2016
    Report Date
    May 12, 2017
    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

    TITLE: KONIA MR ET AL. ANESTHETIC IMPLICATIONS OF CHRONIC LUNG DISEASE IN PATIENTS UNDERGOING TRANSCATHETER VALVE IMPLANTATION. J CARDIOTHORAC VASC ANESTH. (2017) 31 (657¿662). (DOI 10.1053/J.JVCA.2016.08.016) EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE IN NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE OF AN (B)(6) MALE PATIENT SEVERE AORTIC STENOSIS WHO UNDERWENT IMPLANT OF A 31MM MEDTRONIC COREVALVE (SERIAL NUMBER NOT PROVIDED). POST-IMPLANT COMPLETE HEART BLOCK (CHB) DEVELOPED AND A PERMANENT PACEMAKER WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389039 COREVALVE REVALVING SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention