BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC RESOLUTE ONYX STENT

    MDR report key: 11664032 · Received April 13, 2021

    Report

    Report Number
    MW5100765
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 23, 2021
    Report Date
    April 12, 2021
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A PCI ON THE PATIENTS CIRCUMFLEX ARTERY, THE STENT CAME DISLODGED OFF OF THE BALLOON IT WAS MOUNTED ON. THE STENT BECAME DISLODGE IN AN ARTERY IN THE PATIENTS UPPER ARM. THE STENT WAS THEN PULLED BACK WITH WIRES INTO THE RADIAL ARTERY WHERE IT WAS LEFT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555715 MEDTRONIC RESOLUTE ONYX STENT CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC PERFUSION SYSTEMS RONYX30012UX 0010350599

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention