BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2895952 · Received January 4, 2013

    Report

    Report Number
    9612164-2013-00015
    Event Type
    Death
    Date Received
    January 4, 2013
    Date of Event
    June 3, 2012
    Report Date
    January 17, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PULMONARY EDEMA. CONCLUSIONS: PULMONARY EDEMA. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD ONE ENDEAVOR SPRINT STENT IMPLANTED TO THE RCA. APPROXIMATELY 22 MONTHS POST INDEX, PATIENT CARDIAC DEATH OCCURRED. IT WAS REPORTED THAT CAUSE OF DEATH WAS "HAS" AN ACUTE PULMONARY EDEMA. IT WAS ASSESSED THE DEATH EVENT WAS POSSIBLY RELATED TO THE STUDY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5377 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0000871464

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Death ASA