BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3434155 · Received October 23, 2013

    Report

    Report Number
    3434155
    Event Type
    Malfunction
    Date Received
    October 23, 2013
    Date of Event
    October 21, 2013
    Report Date
    October 23, 2013
    Manufacturer
    MEDTRONIC VASCULAR, INC.
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THE STENT PACKAGE WAS OPENED, THE STENT WAS PARTIALLY DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543754 RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC VASCULAR, INC. * 0006818343

    Patients

    Seq Age Sex Outcome Treatment
    1 *