BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COREVALVE EVOLUT R

    MDR report key: 7024558 · Received November 13, 2017

    Report

    Report Number
    7024558
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 31, 2017
    Report Date
    November 7, 2017
    Manufacturer
    MEDTRONIC COREVALVE LLC
    Product Code
    NPT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TAVR DELIVERY DEVICE HAD A KINKING IN THE SHEATH. NOTED BEFORE PLACEMENT INTO PATIENT. DEVICE WAS NOT RETAINED. ANOTHER TYPE OF DEVICE UTILIZED. MANUFACTURER RESPONSE FOR TRANSCATHETER AORTIC VALVE DELIVERY CATHETER SYSTEM COMPRESSION LOADING SYSTEM, MEDTRONIC EVOLUT R 34-45 (PER SITE REPORTER): REP IN ON CASE. DEVICE PROVIDED TO REP. UNKNOWN RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803336 COREVALVE EVOLUT R PROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC COREVALVE LLC MEDTRONIC EVOLUT R 34-45

    Patients

    Seq Age Sex Outcome Treatment
    1