BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 3981564 · Received August 5, 2014

    Report

    Report Number
    2025587-2014-00545
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    June 13, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUBSEQUENTLY, IT WAS REPORTED THAT THE AORTIC REGURGITATION WAS DUE TO A MODERATE PARAVALVULAR LEAK THAT WAS LIKELY DUE TO HEAVY CALCIFICATION OF THE NATIVE ANNULUS, AND NOT VALVE MALPOSITION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, MODERATE AORTIC REGURGITATION WAS NOTED. A VALVULOPLASTY WAS PERFORMED, WITH NO IMPROVEMENT TO THE REGURGITATION. A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED VALVE-IN-VALVE TO REDUCE THE REGURGITATION TO A MILD LEVEL. NO ADDITIONAL INTERVENTION WAS PERFORMED. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456837 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-3143

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Required Intervention