BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3110807 · Received May 14, 2013

    Report

    Report Number
    9612164-2013-00527
    Event Type
    Death
    Date Received
    May 14, 2013
    Date of Event
    January 10, 2013
    Report Date
    May 9, 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 (DEATH). CONCLUSIONS: INHERENT RISK OF PROCEDURE (DEATH). (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT DRUG-ELUTING STENTS IMPLANTED IN THE RCA AND ONE ENDEAVOR SPRINT DRUG -ELUTING STENT IMPLANTED IN THE LAD. IT WAS REPORTED THAT THE PATIENT EXPIRED APPROXIMATELY 18 MONTHS POST INDEX PROCEDURE. THE DEATH WAS ASSESSED AS A CARDIAC DEATH. IT WAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212609 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0002789182

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death CLOPIDOGREL AND ASPIRIN.