BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3954449 · Received July 24, 2014

    Report

    Report Number
    9612164-2014-00990
    Event Type
    Death
    Date Received
    July 24, 2014
    Date of Event
    May 29, 2014
    Report Date
    January 23, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE TWO ENDEAVOR SPRINT DRUG ELUTING STENTS WERE IMPLANTED IN THE RCA. APPROXIMATELY 58 MONTHS POST THE INDEX PROCEDURE THE PATIENT EXPIRED. CAUSE OF DEATH UNKNOWN. THE INVESTIGATOR HAS INDICATED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE CEC HAS ADJUDICATED THE PATIENT'S DEATH AS A CARDIAC DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434012 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00095 YR Death