BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE REVALVING SYSTEM

    MDR report key: 6222879 · Received January 4, 2017

    Report

    Report Number
    2025587-2017-00024
    Event Type
    Injury
    Date Received
    January 4, 2017
    Date of Event
    July 18, 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
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ADITYA MURALIDHARAN ARTICLE TITLE: THE AMERICAN JOURNAL OF CARDIOLOGY 2016; 118(7):1031-45 10.1016/J.AMJCARD.2016.07.011 EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL 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

    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 THE IMPACT OF STROKE AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) IN PREDICTING 30-DAY STROKE-RELATED MORTALITY. THE PRIMARY AIM OF THIS ANALYSIS WAS TO DETERMINE WHETHER PERIOPERATIVE STROKE INCREASES RISK OF STROKE RELATED MORTALITY AFTER TAVI. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN 2009 AND 2015. THE STUDY POPULATION INCLUDED 29,043 PATIENTS, PREDOMINANTLY MALE; MEAN AGE 82 YEARS, A MINIMUM OF 4126 (SOME STUDIES DID NOT INDICATE NUMBERS OF IMPLANT) WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS DEATHS WERE REPORTED DUE TO STROKE, HOWEVER BASED ON THE AVAILABLE INFORMATION, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN A MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: STROKE AND MYOCARDIAL INFARCTION. 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
    7196 COREVALVE REVALVING SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Disability