BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3121509 · Received May 21, 2013

    Report

    Report Number
    9612164-2013-00552
    Event Type
    Death
    Date Received
    May 21, 2013
    Date of Event
    March 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT DRUG ELUTING STENT IMPLANTED IN THE LAD. IT IS REPORTED THAT APPROXIMATELY 28 MONTHS POST INDEX PROCEDURE THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224042 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00094 YR Death CLOPIDOGREL AND ASPIRIN.