BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

    MDR report key: 2103641 · Received May 19, 2011

    Report

    Report Number
    9612164-2011-00448
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    January 23, 2011
    Report Date
    April 21, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT OVER THE WIRE (OTW) DRUG ELUTING STENT WAS IMPLANTED IN THE MID LCX DURING THE INDEX PROCEDURE. IT IS REPORTED THAT APPROXIMATELY 3 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A SPONTANEOUS GASTROINTESTINAL (GI) BLEED. THE PATIENT WAS ADMITTED WITH GI BLEED AND ANEMIA. IT IS REPORTED THAT EVENT LEAD TO A HEMODYNAMIC COMPROMISE. THE PATIENT RECEIVED 5 UNITS OF PRBC'S AND 2 UNITS OF PLASMA. INVESTIGATOR HAS INDICATED THAT 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 66 YR Required Intervention CLOPIDOGREL| ASPIRIN