BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

    MDR report key: 2230591 · Received August 11, 2011

    Report

    Report Number
    9612164-2011-00908
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 15, 2011
    Manufacturer
    MEDTRONIC IRELAND
    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). RESULTS: (GI BLEED).

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT OVER THE WIRE (OTW) DRUG ELUTING STENT WAS IMPLANTED IN THE MID RCA DURING INDEX PROCEDURE. IT IS REPORTED THAT APPROXIMATELY 11.5 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A SPONTANEOUS GASTROINTESTINAL (GI) BLEED. IT IS REPORTED THAT THE PATIENT WAS ADMITTED FOR VOMITING BLOOD. UPPER ENDOSCOPY SHOWED ACUTE GASTRITIS, HIATAL HERNIA AND POSSIBLE DIEULAFOY LESION AT GASTROESOPHAGEAL JUNCTION. CAUTERIZATION OF GASTRITIS WAS DONE DURING PROCEDURE. INVESTIGATOR HAS INDICATED THAT GI BLEED EVENT WAS NOT RELATED TO STUDY STENT OR PROCEDURES. PATIENT WAS TAKING ASPIRIN AND CLOPIDOGREL 24 HOURS PRIOR TO THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention CLOPIDOGREL| ASPIRIN