BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT OTW

    MDR report key: 3882695 · Received June 19, 2014

    Report

    Report Number
    9612164-2014-00649
    Event Type
    Death
    Date Received
    June 19, 2014
    Date of Event
    April 18, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT DRUG ELUTING STENT AND ONE NON MEDTRONIC STENT WERE IMPLANTED DURING INDEX PROCEDURE. IT IS REPORTED THAT APPROXIMATELY 36 MONTHS POST INDEX PROCEDURE THE PATIENT EXPIRED. CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360569 ENDEAVOR SPRINT OTW STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005018480

    Patients

    Seq Age Sex Outcome Treatment
    1 Death