BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8844910 · Received July 31, 2019

    Report

    Report Number
    9612164-2019-03132
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    May 8, 2019
    Report Date
    April 6, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    UDI-DI
    00643169556829
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE SITE (INVESTIGATOR) ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION: CEC ADJUDICATED THE EVENT DATE AS (B)(6) 2019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CEC ADJUDICATED THE EVENT AS LATE STENT THROMBOSIS, ARC DEFINITE IN THE RCA AND THAT IT IS RELATED TO THE STUDY STENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX STENTS WERE IMPLANTED - ONE INTO THE 1ST DIAGONAL AND ONE INTO THE LAD. DURING A STAGED PROCEDURE FOUR RESOLUTE ONYX STENTS WERE IMPLANTED INTO THE RCA. APPROX 5 MONTHS POST STAGED PROCEDURE THE PATIENT SUFFERED NSTEMI OF THE RCA AND TOTAL OCCLUSION OF THE RCA. THE PATIENT RECEIVED A LEFT HEART CATH AND WAS TREATED WITH MEDICATION. THE INVESTIGATOR AND SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION. THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642378 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND RONYX25022UX 0009320711 00643169556829

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R