BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3133320 · Received May 29, 2013

    Report

    Report Number
    9612164-2013-00585
    Event Type
    Death
    Date Received
    May 29, 2013
    Date of Event
    March 10, 2013
    Report Date
    May 13, 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

    DURING INDEX PROCEDURE THE PATIENT HAD THREE ENDEAVOR SPRINT DRUG ELUTING STENTS IMPLANTED, ONE IN THE RCA AND TWO IN THE OBTUSE MARGINAL. IT IS REPORTED THAT APPROXIMATELY 18 MONTHS POST INDEX PROCEDURE THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS ACUTE MYOCARDIAL INFARCTION.

    Description of Event or Problem · 1

    INVESTIGATOR HAS INDICATED THE PREVIOUSLY REPORTED MI AND PATIENT DEATH EVENTS WERE POSSIBLY RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236844 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005207161

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Death CLOPIDOGREL AND ASPIRIN.