BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2003668 · Received February 24, 2011

    Report

    Report Number
    2953200-2011-00499
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    June 7, 2010
    Report Date
    January 27, 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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS WERE IMPLANTED, ONE IN THE MID LAD AND ONE IN THE MID RCA. IT IS REPORTED THAT THE PT SUFFERED A SPONTANEOUS GASTROINTESTINAL (GI) BLEED THREE DAYS POST INDEX PROCEDURE. THE PT WAS TAKING ASPIRIN, BUT NOT CLOPIDOGREL AT THE TIME OF THE EVENT. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 30 DAY FOLLOW UP. PT'S CARDIAC STATUS AT 6 MONTH FOLLOW UP WAS STABLE ANGINA AND AT 1 YEAR FOLLOW UP WAS UNSTABLE ANGINA. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 1.5 YEAR FOLLOW UP. IT IS REPORTED THAT THE PT SUFFERED AN ACUTE NON-STEMI APPROXIMATELY 25 MONTHS POST INDEX PROCEDURE. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO STUDY PROCEDURE. (REF MFR # 2953200-2011-00500).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000553770

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization ASPIRIN