BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2991963 · Received March 7, 2013

    Report

    Report Number
    9612164-2013-00253
    Event Type
    Death
    Date Received
    March 7, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 14, 2013
    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

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (MI, DEATH). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PREVIOUSLY REPORTED MI OCCURRED 10 DAYS BEFORE PATIENT DEATH AND THE MI WAS RELATED TO THE TARGET VESSEL, AND NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PATIENT HAD TWO ENDEAVOR SPRINT DRUG-ELUTING STENTS IMPLANTED IN THE LAD. THE PATIENT DIED APPROXIMATELY 13 MONTHS POST INDEX PROCEDURE. CAUSE OF DEATH WAS ASSESSED AS DUE TO AN MI. THE INVESTIGATOR ASSESSED THAT THE DEATH WAS NOT RELATED TO THE STUDY DEVICE. THE RELATIONSHIP BETWEEN THE MI AND THE STUDY DEVICE WAS NOT ASSESSED. PATIENT WAS ON ASPIRIN PRIOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97487 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005562128

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death ASPIRIN