BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8132214 · Received December 5, 2018

    Report

    Report Number
    9612164-2018-03469
    Event Type
    Injury
    Date Received
    December 5, 2018
    Date of Event
    September 27, 2017
    Report Date
    September 9, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    UDI-DI
    00643169557017
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: PATIENT AGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: CEC ADJUDICATED MI AS NO EVENT, BUT REVASCULARIZATION OF THE LCMA, CM, 1ST OM AND GRAFT 1ST DIAG ARE DUE TO STENT THROMBOSIS EVENT TYPE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE 1ST DIAG, LCMA AND CX. ON THE SAME DAY, CORONARY ARTERY PLAQUE SHIFT INTO THE 1ST OM WAS REPORTED. THIS WAS TREATED WITH AN UNKNOWN BRANDED BALLOON. APPROXIMATELY THREE MONTHS LATER ANOTHER RESOLUTE ONYX DES WAS IMPLANTED FOR TARGET LESION TREATMENT. THE INVESTIGATOR ASSESSED THE EVENT AS PROBABLY RELATED TO THE DEVICE AND NOT RELATED TO THE ANTIPLATELET MEDICATION. THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971814 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND RONYX30026UX 0008671549 00643169557017

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R