BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2000819 · Received February 17, 2011

    Report

    Report Number
    2953200-2011-00425
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    June 1, 2010
    Report Date
    January 20, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - RESULTS: (GI BLEED).

    Description of Event or Problem · 1

    THREE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS WERE IMPLANTED; TWO IN THE MID RCA AND ONE IN THE RIGHT PDA. AT ONE MONTH AND SIX MONTH F/U'S, PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS. IT IS REPORTED THAT THE PT SUFFERED A GASTROINTESTINAL (GI) BLEED APPROX 10 MONTHS POST INDEX PROCEDURE. IT IS REPORTED THAT PLAVIX WAS STOPPED FOR FIVE DAYS AND THE PT WAS PUT ON FLOMAX. PT WAS TAKING ASPIRIN AND CLOPIDOGREL 24 HRS BEFORE THE EVENT. IT IS REPORTED THAT THE PT RECOVERED WITH TREATMENT. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO EITHER THE STUDY DEVICE OR THE STUDY PROCEDURE. AT 1 YR AND 1.5 YR F/U'S PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS. (REF MFR# 2953200-2011-00423 AND 2953200-2011-424).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention ASPIRIN.| CLOPIDOGREL.| ASPIRIN| CLOPIDOGREL