BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2230618 · Received August 11, 2011

    Report

    Report Number
    9612164-2011-00913
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (HEMORRHAGE REQUIRING TRANSFUSION).

    Description of Event or Problem · 1

    FOUR ENDEAVOR SPRINT RX DRUG ELUTING STENTS WERE IMPLANTED IN THE MID RCA DURING THE INDEX PROCEDURE. A STAGED PROCEDURE WAS CARRIED OUT ONE WEEK POST THE INDEX PROCEDURE, AN ENDEAVOR SPRINT RX DRUG ELUTING STENT WAS IMPLANTED IN THE PROX LCX. PATIENT WAS REPORTED TO BE ASYMPTOMATIC / FREE OF SYMPTOMS AT THE 30 DAY, 6 MONTH, 1 YEAR, 1.5 YEAR, 2 YEAR, 2.5 YEAR AND 3 YEAR FOLLOW UPS. APPROXIMATELY 3 YEARS AND FOUR MONTHS POST THE INDEX PROCEDURE THE PATIENT EXPERIENCED SPONTANEOUS GASTRO-INTESTINAL BLEEDING. THE PATIENT HAD BEEN TAKING ASA, CLOPIDOGREL/TICLOPIDINE PRIOR TO THE EVENT. THE INVESTIGATOR HAS INDICTED THE EVENT WAS NOT RELATED TO THE STUDY STENT. AUTO TRANSFUSION OF 2 UNITS WAS CARRIED OUT. (REF MFR # 9612164201100914, 9612164201100915, 9612164201100916 AND 9612164201100917).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE PATIENT WAS TAKING ASA| AND CLOPIDOGREL/TICLOPIDINE 24 HOURS| PRIOR TO THE EVENT