BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3781668 · Received April 30, 2014

    Report

    Report Number
    9612164-2014-00463
    Event Type
    Death
    Date Received
    April 30, 2014
    Date of Event
    October 21, 2013
    Report Date
    April 25, 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

    EVALUATION, RESULTS, CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (CVA/STROKE). (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR SPRINT DRUG ELUTING STENT IMPLANTED TO THE LAD AND ONE ENDEAVOR SPRINT DRUG ELUTING STENT IMPLANTED TO THE RCA. APPROXIMATELY 28 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED A STROKE AND EXPIRED THE FOLLOWING DAY. INVESTIGATOR ASSESSED THAT THE REPORTED EVENTS WERE NOT RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260526 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0002966645

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Death