BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT R VALVE DELIVERY SYSTEM

    MDR report key: 7529448 · Received May 21, 2018

    Report

    Report Number
    7529448
    Event Type
    Malfunction
    Date Received
    May 21, 2018
    Date of Event
    May 8, 2018
    Report Date
    May 16, 2018
    Manufacturer
    MEDTRONIC COREVALVE LLC
    Product Code
    NPT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NOSE CONE OF DELIVERY SHEATH BROKE INTO END OF SHEATH; IMMEDIATELY RETRIEVED BY DR. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373606 EVOLUT R VALVE DELIVERY SYSTEM AORTIC TRANSCATHETER HEART VALVE BIOPROSTHESIS, STENT-LIKE FRAMEWORK NPT MEDTRONIC COREVALVE LLC ENVEOR-US 8945842

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR