BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2841547 · Received November 21, 2012

    Report

    Report Number
    9612164-2012-01687
    Event Type
    Death
    Date Received
    November 21, 2012
    Date of Event
    January 2, 2012
    Report Date
    January 16, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (MYOCARDIAL INFARCTION, DEATH). CONCLUSIONS: INHERENT RISK OF PROCEDURE (MYOCARDIAL INFARCTION, DEATH). (B)(4).

    Description of Event or Problem · 1

    THERE WAS ONE ENDEAVOR SPRINT DRUG ELUTING STENT IMPLANTED IN THE LAD DURING THE INDEX PROCEDURE. IT IS REPORTED THAT THE PATIENT DIED DUE TO CARDIAC ARRHYTHMIA, MYOCARDIAL INFARCTION, RENAL INSUFFICIENCY AND ISCHEMIC DISEASE APPROXIMATELY 14 MONTHS POST INDEX PROCEDURE. INVESTIGATOR ASSESSED THAT THE EVENT WAS UNLIKELY TO BE RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    INVESTIGATOR ASSESSED THAT THE PREVIOUSLY REPORTED MI THAT THE PATIENT SUFFERED ON THE SAME DAY AS PATIENT DEATH WAS POSSIBLY RELATED TO THE STUDY DEVICE. IT IS UNKNOWN IF THE REPORTED MI WAS RELATED TO THE TARGET VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0001060403

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Death CLOPIDOGREL AND ASPIRIN.