BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE REVALVING SYSTEM

    MDR report key: 6220142 · Received January 3, 2017

    Report

    Report Number
    2025587-2017-00015
    Event Type
    Injury
    Date Received
    January 3, 2017
    Date of Event
    November 1, 2016
    Report Date
    December 9, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: OPEYEMI O. FADAHUNSI, MPH ARTICLE TITLE. INCIDENCE, PREDICTORS, AND OUTCOMES OF PERMANENT PACEMAKER IMPLANTATION FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT ANALYSIS FROM THE U.S. SOCIETY OF THORACIC SURGEONS/ AMERICAN COLLEGE OF CARDIOLOGY J A C C : CARDI O V A SC U LAR INT E RVENT IONS 2016 9(21):2189-2199 10.1016/J.JCIN.2016.07.026 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. 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

    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 TO EVALUATE THE INCIDENCE, PREDICTORS, AND CLINICAL OUTCOMES OF PERMANENT PACEMAKER (PPM) IMPLANTATION FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN NOVEMBER 2011 AND SEPTEMBER 2014. THE STUDY POPULATION INCLUDED 9,785 PATIENTS, PREDOMINANTLY FEMALE; MEAN AGE 84 YEARS. THE NUMBER OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE WAS NOT SPECIFIED (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANT FOR CONDUCTION DISORDERS, CONGESTIVE HEART FAILURE (CHF), STROKE AND MYOCARDIAL INFARCTION (MI). MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND A MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3160 COREVALVE REVALVING SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention