BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3915119 · Received July 7, 2014

    Report

    Report Number
    9612164-2014-00708
    Event Type
    Death
    Date Received
    July 7, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PATIENT HAD TWO ENDEAVOR SPRINT DRUG-ELUTING STENTS IMPLANTED IN THE LAD. APPROXIMATELY 4 YEARS, 11 MONTHS POST THE INDEX PROCEDURE, PATIENT DEATH OCCURRED. THE CAUSE OF DEATH IS UNKNOWN. THE RELATIONSHIP BETWEEN THE EVENT AND THE STUDY DEVICES WAS NOT ASSESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393318 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Death