BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE REVALVING SYSTEM

    MDR report key: 6766993 · Received August 4, 2017

    Report

    Report Number
    2025587-2017-01291
    Event Type
    Injury
    Date Received
    August 4, 2017
    Date of Event
    July 4, 2017
    Report Date
    July 10, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: V. AUFFRET ET AL, "TEMPORAL TRENDS IN TRANSCATHETER AORTIC VALVE REPLACEMENT IN FRANCE FRANCE 2 TO FRANCE TAVI", J AM COLL CARDIOL 2017;70:42¿55. DOI: HTTP://DX.DOI.ORG/10.1016/J.JACC.2017.04.053 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING TEMPORAL TRENDS IN TRANSCATHETER AORTIC VALVE REPLACEMENT IN FRANCE - FRANCE 2 TO FRANCE TAVI. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN JANUARY 2013 AND DECEMBER 2015 FOR FRANCE TAVI REGISTRY, AND JANUARY 2010 TO JANUARY 2012 FOR FRANCE 2 REGISTRY. THE STUDY'S POPULATION INCLUDED 16 ,969 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 85 YEARS), 5,871 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS DEATH/MORTALITY WAS NOTED, HOWEVER BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: ANNULUS RUPTURE, AORTIC DISSECTION, VALVE MIGRATION, TAMPONADE, STROKE, MYOCARDIAL INFARCTION, PERMANENT PACEMAKER IMPLANT, PULMONARY EMBOLISM, RENAL FAILURE/DIALYSIS, MODERATE OR SEVERE AORTIC REGURGITATION (AR), MODERATE OR SEVERE MITRAL REGURGITATION (MR), AND MODERATE OR SEVERE PARAVALVULAR LEAK (PVL). BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548042 COREVALVE REVALVING SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening| R