BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1960874 · Received January 12, 2011

    Report

    Report Number
    2953200-2011-00072
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    July 16, 2010
    Report Date
    December 13, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (CVA/STROKE).

    Description of Event or Problem · 1

    THREE ENDEAVOR SPRINT RAPID EXCHANGE DRUG-ELUTING STENTS WERE IMPLANTED; ONE TO THE DISTAL LAD, ONE TO THE PROXIMAL LAD AND ONE TO THE RIGHT PDA. PT WAS DISCHARGED ONE DAY POST INDEX PROCEDURE ON ASPIRIN AND CLOPIDOGREL. THE PT WAS ASYMPTOMATIC AT 30 DAY, 6 MONTH AND 1 YEAR FOLLOW UPS. APPROX ONE YEAR AND ELEVEN MONTHS POST INDEX PROCEDURE THE PT SUFFERED AN ISCHEMIC STROKE. PT PRESENTED TO THE HOSPITAL WITH DISARTRIA. PT WAS ADMITTED FOR 7 DAYS AND RECOVERED COMPLETELY WITHOUT CHANGES IN THE PREVIOUS TREATMENT. THE EVENT WAS NOT CLASSIFIED AS LIFE THREATENING. IT IS REPORTED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT/ PROCEDURE. (REF. MFR. # 2953200-2011-00070, 2953200-2011-00071).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000748744

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization PT WAS ON ASPIRIN 24 HRS BEFORE THE EVENT.