BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7074579 · Received December 1, 2017

    Report

    Report Number
    2025587-2017-02311
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    September 10, 2015
    Report Date
    December 1, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SANTARPINO G. CLINICAL OUTCOME AND COST ANALYSIS OF SUTURELESS VERSUS TRANSCATHETER AORTIC VALVE IMPLANTATION WITH PROPENSITY SCORE MATCHING ANALYSIS. AM J CARDIOL. 2015 DEC 1;116(11):1737-43. DOI: 10.1016/J.AMJCARD.2015.08.043 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. 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 CLINICAL OUTCOME AND COST ANALYSIS OF SUTURELESS VERSUS TRANSCATHETER AORTIC VALVE IMPLANTATION WITH PROPENSITY SCORE MATCHING ANALYSIS. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2010 AND 2015. THE STUDY POPULATION INCLUDED 626 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 80 YEARS), AN UNSPECIFIED NUMBER OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE DEVICE. (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS 10 DEATHS OCCURRED. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENT¿S ADVERSE EVENTS INCLUDED: PARAVALVULAR LEAKAGE, VALVE MIGRATION INTO LEFT VENTRICLE WITH CONVERSION TO SURGICAL REPAIR, VASCULAR COMPLICATIONS REQUIRING INTERVENTION, AORTIC INJURY DUE TO GUIDEWIRE MANIPULATION, PACEMAKER IMPLANTATION, AND VENTRICULAR FIBRILLATION REQUIRING CARDIOPULMONARY BYPASS (CPB) FOR CIRCULATORY SUPPORT. 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 MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853988 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention