BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7162037 · Received January 3, 2018

    Report

    Report Number
    2025587-2018-00037
    Event Type
    Injury
    Date Received
    January 3, 2018
    Date of Event
    December 1, 2012
    Report Date
    January 3, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: HAYASHIDA ET AL. IMPACT OF POST-PROCEDURAL AORTIC REGURGITATION ON MORTALITY AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION . JACC CARDIOVASC INTERV. 2012 DEC;5(12):1247-56. DOI: 10.1016/J.JCIN.2012.09.003. 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. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING THE IMPACT OF POST-PROCEDURAL AORTIC REGURGITATION (AR) ON CLINICAL OUTCOMES. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN OCTOBER 2006 AND OCTOBER 2011. THE STUDY POPULATION INCLUDED 400 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 83.4 YEARS), 53 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE BIOPROSTHETIC VALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, 109 DEATHS OCCURRED DURING A FOLLOW-UP PERIOD WITH A MEDIAN OF 297 DAYS. THE CUMULATIVE INCIDENCE OF MORTALITY AT 2 YEARS WAS 28.0%, 40.4%, AND 75.0%, RESPECTIVELY. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: POST-PROCEDURAL AR, ANNULUS RUPTURE, ACUTE KIDNEY INJURY, MAJOR VASCULAR COMPLICATION, AND ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT. 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 OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5199 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention