BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3883326 · Received June 19, 2014

    Report

    Report Number
    9612164-2014-00652
    Event Type
    Death
    Date Received
    June 19, 2014
    Date of Event
    November 7, 2011
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, 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 THREE ENDEAVOR SPRINT DRUG-ELUTING STENTS IMPLANTED. APPROXIMATELY 17 MONTHS POST THE INDEX PROCEDURE, PATIENT DEATH OCCURRED. CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360627 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0001306432

    Patients

    Seq Age Sex Outcome Treatment
    1 Death