BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 6819730 · Received August 25, 2017

    Report

    Report Number
    9612164-2017-01163
    Event Type
    Injury
    Date Received
    August 25, 2017
    Date of Event
    July 28, 2017
    Report Date
    May 1, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    UDI-DI
    00643169556782
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CEC ASSESSED MI AS NON Q WAVE MI (NON TARGET VESSEL), MDT EXTENDED HISTORICAL SPONTANEOUS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CEC ASSESSED THE REVASCULARISATION AS A NON TVR SURGERY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CEC READJUDICATED THE REVASCULARISATION AS A NON TVR PERCUTANEOUS INTERVENTION OF THE GRAFT 1ST DIAG. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS A MEDICAL HISTORY OF CHRONIC LEFT BUNDLE BRANCH BLOCK AND TIA. AS WELL AS THE CEC ALREADY ASSESSING THE MI AS NON Q WAVE MI (NON TARGET VESSEL), MDT EXTENDED HISTORICAL SPONTANEOUS, THE CEC ALSO ADJUDICATED THE MI AS NO SCAI EVENT. 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.

    Additional Manufacturer Narrative · 1

    THE CEC ADJUDICATED THE EVENT AS A NON Q WAVE MI (NON TARGET VESSEL), MDT EXTENDED HISTORICAL SPONTANEOUS-NO EVENT. THE CEC ALSO ADJUDICATED THE STENT THROMBOSIS AS NO EVENT. THE PATIENT HAS A MEDICAL HISTORY OF ARRHYTHMIA. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE EVENT IS NOT RELATED TO THE STUDY DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE INDEX PROCEDURE WAS PROMPTED BY STABLE ANGINA AND AN MI. DURING THE INDEX PROCEDURE, TWO RESOLUTE ONYX DES WERE IMPLANTED INTO THE PROXIMAL CX. APPROXIMATELY 18 DAYS POST INDEX PROCEDURE, THE PATIENT SUFFERED AN NSTEMI. THE EVENT WAS TREATED WITH A PCI OF THE SVG-DIAG. THE PATIENT RECOVERED ON THE SAME DAY. IT IS UNKNOWN IF THE EVENT IS RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601639 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0008532059 00643169556782

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention