BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 4191641 · Received October 22, 2014

    Report

    Report Number
    9612164-2014-01354
    Event Type
    Death
    Date Received
    October 22, 2014
    Date of Event
    November 16, 2013
    Report Date
    October 14, 2014
    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

    EVALUATION C RESULTS: INHERENT RISK OF PROCEDURE ¿ (DEATH) EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (DEATH).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PATIENT HAD 2 ENDEAVOR SPRINT DRUG-ELUTING STENTS IMPLANTED IN THE RCA. IT IS REPORTED THAT THE PATIENT EXPIRED APPROX. 39 MONTHS POST INDEX PROCEDURE. CAUSE OF DEATH IS UNKNOWN. IT IS UNKNOWN IF THE EVENT WAS RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673210 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Death