BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1905370 · Received November 18, 2010

    Report

    Report Number
    2953200-2010-02264
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    September 2, 2010
    Report Date
    October 22, 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
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A 3.5MM DIAMETER X 24MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT WAS DEPLOYED IN THE PROX LAD OF A PT WITH NO ISSUE REPORTED. HOWEVER, IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS POST IMPLANT, PRESENTED WITH SYMPTOMS OF GI BLEEDING. THE PT WAS ON DUAL ANTIPLATELET THERAPY WHEN THE EVENT OCCURRED. THE PT WAS HOSPITALIZED AND MEDICATION WAS ADMINISTERED. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000922585

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization NITRATE| COLCHICINA| ASA| CLOPIDOGREL| CA++ ANTAGONIST| BETA BLOCKER