BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2223879 · Received August 18, 2011

    Report

    Report Number
    9612164-2011-00976
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 24, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: MI.

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS WERE IMPLANTED DURING THE INDEX PROCEDURE; ONE IN THE MID LAD AND ONE IN THE LEFT MAIN. IT IS REPORTED THAT THE PATIENT SUFFERED A MYOCARDIAL INFRACTION (MI) ON THE SAME DAY AS INDEX PROCEDURE. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR THE TARGET VESSEL. (REF MFR # 9612164-2011-00975).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0000941889

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR ASA| CLOPIDOGREL