BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8447543 · Received March 25, 2019

    Report

    Report Number
    9612164-2019-01017
    Event Type
    Injury
    Date Received
    March 25, 2019
    Date of Event
    February 20, 2019
    Report Date
    May 8, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    UDI-DI
    00643169556898
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    CEC ASSESSED MYOCARDIAL INFARCTION AS A NON Q WAVE MI (TARGET VESSEL), 3RD UDMI SPONTANEOUS. CEC ASSESSED REVASCULARISATION AS A TARGET VESSEL REVASCULARISATION, PERCUTANEOUS INTERVENTION NOT INVOLVING THE TARGET LESION THAT WAS CLINICALLY DRIVEN. CEC COMMENTED TVR FOR BOTH LAD AND DIAGONAL. STENT IS PATENT. CEC ASSESSED STENT THROMBOSIS AS NO EVENT. CEC COMMENTED THE DIAGONAL WAS JAILED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, TWO RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED; ONE IN THE CIRCUMFLEX AND OTHER IN THE LAD. THIRTY-TWO DAYS POST PROCEDURE, NSTEMI OF THE TARGET VESSEL WAS REPORTED AND TREATED WITH MEDICATION AND REVASCULARIZATION WITH A DRUG-ELUTING STENT IMPLANTED IN THE LAD. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO THE DEVICE AND ANTIPLATELETS. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO THE DEVICE AND UNLIKELY RELATED TO THE ANTIPLATELETS. PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242309 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0009159511 00643169556898

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other| R