BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX

    MDR report key: 3747510 · Received April 14, 2014

    Report

    Report Number
    9612164-2014-00394
    Event Type
    Death
    Date Received
    April 14, 2014
    Date of Event
    August 7, 2013
    Report Date
    April 8, 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

    (B)(4). RESULTS AND CONCLUSIONS: (DEATH).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR DRUG-ELUTING STENT IMPLANTED TO THE RIGHT PAV. A NON-MEDTRONIC STENT WAS ALSO IMPLANTED TO THE DISTAL RCA. APPROXIMATELY 48 MONTHS POST INDEX THE PATIENT DIED. THE CAUSE OF DEATH WAS INDICATED AS CARDIAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227511 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Death