BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 4222815 · Received November 4, 2014

    Report

    Report Number
    9612164-2014-01415
    Event Type
    Death
    Date Received
    November 4, 2014
    Date of Event
    August 8, 2014
    Report Date
    December 23, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE ¿ (DEATH); CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (DEATH). (B)(4).

    Description of Event or Problem · 1

    THE PREVIOUSLY REPORTED CARDIAC ARREST AND DEATH EVENT WAS TREATED WITH CPR AND CONTINUOUS INTRAVENOUS NOREPINEPHRINE AND DOBUTAMINE. THE CEC ADJUDICATED THE DEATH EVENT AS A CARDIAC DEATH.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR RESOLUTE (RX) DRUG ELUTING STENT IMPLANTED IN THE 1ST RPL. APPROXIMATELY 50 MONTHS POST INDEX PROCEDURE, THE PATIENT HAD ONE RESOLUTE INTEGRITY DRUG ELUTING STENT IMPLANTED IN THE LAD DUE TO CARDIAC CHEST PAIN. APPROXIMATELY 58 MONTHS POST INDEX PROCEDURE, SUFFERED CARDIAC ARREST AND THE PATIENT DIED. DEATH WAS ASSESSED AS CARDIAC. CAUSE OF DEATH IS UNKNOWN. INVESTIGATOR ASSESSED THAT THE CARDIAC ARREST EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE DEATH WAS NOT ASSESSED FOR RELATEDNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707295 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006851989

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Death| R