BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE REVALVING SYSTEM

    MDR report key: 6257078 · Received January 17, 2017

    Report

    Report Number
    2025587-2017-00100
    Event Type
    Injury
    Date Received
    January 17, 2017
    Date of Event
    November 1, 2016
    Report Date
    December 23, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: NEW GENERATION DEVICES FOR TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (BOSTON SCIENTIFIC LOTUS VALVE AND EDWARDS SAPIEN 3) ARE SUPERIOR COMPARED WITH LAST GENERATION DEVICES (EDWARDS XT AND MEDTRONIC COREVALVE) WITH RESPECT TO VARC-2 OUTCOME CITATION: JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY (2016) 68(18S):B301 (DOI 10.1016/J.JACC.2016.09.157) AUTHORS: JULIA SEEGER, BIRGID GONSKA, CHRISTOPH RODEWALD, WOLFGANG ROTTBAUER, JOCHEN WÖHRLE 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. 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 REVIEW REGARDING THE 30 DAY OUTCOMES OF THE ¿NEW GENERATION¿ VERSUS THE ¿LAST GENERATION¿ OF TRANSCATHETER BIOPROSTHETIC AORTIC VALVES. ALL DATA WERE COLLECTED FROM BETWEEN 2010 AND 2015. THE STUDY POPULATION INCLUDED 400 PATIENTS, 100 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE. AMONG ALL PATIENTS IMPLANTED WITH A COREVALVE, ADVERSE EVENTS INCLUDED: 21 INCIDENTS OF SECOND OR THIRD DEGREE HEART BLOCK THAT WERE TREATED WITH THE PLACEMENT OF A PERMANENT PACEMAKER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39641 COREVALVE REVALVING SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention