BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1230184 · Received November 13, 2008

    Report

    Report Number
    2953200-2008-01053
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    July 27, 2008
    Report Date
    October 17, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER, SECONDARY INTERVENTION - OTHER, SPONTANEOUS BLEED - EVALUATION RESULTS: SPONTANEOUS GI BLEED.

    Description of Event or Problem · 1

    FIVE ENDEAVOR SPRINT DRUG-ELUTING STENTS WERE IMPLANTED IN AN OVERLAPPING FASHION. (MFR REPORT# 2953200-2008-01053-01057). INVESTIGATOR REPORTED A SPONTANEOUS GI BLEED OCCURRED SIX DAYS LATER, WHILE ON ANTIPLATELET THERAPY. PATIENT REQUIRED 5 UNITS OF AUTO-TRANSFUSION. INVESTIGATOR HAS INDICATED THAT EVENT WAS NOT RELATED TO THE STUDY STENT. PATIENT WAS ASYMPTOMATIC AT 30 DAY FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000745405

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention