BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX

    MDR report key: 3192687 · Received June 27, 2013

    Report

    Report Number
    9612164-2013-00674
    Event Type
    Death
    Date Received
    June 27, 2013
    Date of Event
    January 3, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS, CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (DEATH). (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR DRUG ELUTING STENT IMPLANTED IN THE LAD. IT IS REPORTED THAT APPROXIMATELY 55 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS SUDDEN DEATH. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292696 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0000408601

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Death ASPIRIN