BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1850902 · Received September 29, 2010

    Report

    Report Number
    2953200-2010-01853
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    June 20, 2010
    Report Date
    September 2, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A 3.0MM DIAMETER X 15MM LENGTH ENDEAVOR SPRINT RX DRUG-ELUTING CORONARY STENT WAS DEPLOYED IN THE DISTAL CLX OF A PT WITH NO ISSUE REPORTED. HOWEVER, IT WAS REPORTED THAT THE PT WAS HOSPITALIZED DUE TO A GI BLEEDING EVENT 9 MONTHS POST IMPLANT OF THE RELEVANT STENT. THE PT IS REPORTED TO BE RECOVERED AND NO OTHER CLINICAL SEQUELAE WERE REPORTED. INVESTIGATOR REPORTED THAT THE EVENT IS NOT RELATED TO THE RELEVANT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000903573

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization DUAL ANTIPLATELET THERAPY