BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8260125 · Received January 18, 2019

    Report

    Report Number
    9612164-2019-00238
    Event Type
    Death
    Date Received
    January 18, 2019
    Date of Event
    January 1, 2019
    Report Date
    July 31, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATOR ASSESSED THE MI AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO ANTI-PLATELET MEDICATION. MI WAS DUE TO IN-STENT RESTENOSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: CEC ADJUDICATED NON-Q-WAVE MI (TARGET VESSEL), 3RD UDMI SPONTANEOUS, PROX CX, LCMA. CEC ADJUDICATED DEATH, CARDIAC. CEC ADJUDICATED TLR-PCI AS CLINICALLY DRIVEN OF LCMA AND CX, REASON FOR REVASCULARIZATION: CLINICAL JUDGEMENT. CEC ADJUDICATED LATE STENT THROMBOSIS, ARC DEFINITE- LCMA <(>&<)> CX, DUE TO OCCLUSION OF LEFT MAIN/LCX IN SETTING OF ACUTE MI STENT THROMBOSIS. CEC ALSO ADJUDICATED THROMBOTIC OCCLUSION OF THE STUDY STENT DID NOT OCCUR SUBSEQUENT TO REPEAT PCI OF THE TARGET LESION AND THE STENT THROMBOSIS IS NOT RELATED TO A NON STUDY STENT OR TO NON TARGET LESION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS TAKING DUAL ANTIPLATELET THERAPY WITHIN 24 HOURS PRIOR TO THE 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.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX STENTS WERE IMPLANTED INTO THE CX AND ONE RESOLUTE ONYX STENT WAS IMPLANTED INTO THE LCMA. APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED CARDIOGENIC SHOCK. MYOCARDIAL INFARCTION OF THE TARGET VESSELS- LCX AND LM WAS ALSO REPORTED. THE PATIENT WAS TREATED WITH PTCA AND STENTING BUT PASSED AWAY. THE PATIENTS DEATH WAS CLASSIFIED AS NON SUDDEN CARDIAC DEATH. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICE AND UNLIKELY TO BE RELATED TO ANTI-PLATELET MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55613 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0009110296

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| H| R