BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2955619 · Received February 11, 2013

    Report

    Report Number
    9612164-2013-00157
    Event Type
    Death
    Date Received
    February 11, 2013
    Date of Event
    March 26, 2011
    Report Date
    January 28, 2013
    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

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

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD FOUR ENDEAVOR SPRINT DRUG ELUTING STENTS IMPLANTED IN THE LAD. APPROXIMATELY 2 MONTHS POST INDEX PROCEDURE THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS CARDIAC ARREST. THE INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58175 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death DUAL ANTIPLATELET THERAPY