BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2251331 · Received September 13, 2011

    Report

    Report Number
    9612164-2011-01129
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    March 2, 2011
    Report Date
    April 26, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RX DRUG-ELUTING STENTS WERE SUCCESSFULLY IMPLANTED DURING INDEX PROCEDURE. ONE STENT (3.50 X 15 MM) WAS IMPLANTED TO PROXIMAL LAD; ONE STENT (3.00 X 30 MM) WAS IMPLANTED TO MID LAD. TWO ENDEAVOR SPRINT RX STENTS WERE SUCCESSFULLY IMPLANTED DURING REVASCULARIZATION. ONE STENT (3.50 X 30 MM) WAS IMPLANTED TO LEFT MAIN; ONE STENT (4.00 X 24 MM) WAS IMPLANTED IN THE PROXIMAL LCX. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 30 DAYS, 6 MONTHS, 1, 1.5, 2, 2.5 AND 3 YEARS F/U. AN SPONTANEOUS GI BLEED IS REPORTED TO HAVE OCCURRED APPROX 1 YEAR 9 MONTHS FOLLOWING INDEX PROCEDURE. INVESTIGATOR HAS INDICATED THAT EVENT WAS NOT RELATED TO THE STUDY STENT OR STUDY PROCEDURES. (RE MFR#S 9612164-2011-01130, 01131 AND 01132).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE 2ND STENT IN STAGED PROCEDURE WAS IMPLANTED TO THE PROXIMAL CIRCUMFLEX. INFORMATION RECEIVED (B)(6) 2011 CONFIRMED SITE OF IMPLANT AS MID LEFT CIRCUMFLEX. APPROXIMATELY 2 YEARS <(>&<)> 2 MONTHS POST INDEX PROCEDURE THE PATIENT WAS REHOSPITALIZED DUE TO AN HEMOPERICARDIAL BLEED. REVASCULARIZATION WAS REQUIRED PTCA OF THE PROXIMAL LEFT CIRCUMFLEX AND MID LEFT CIRCUMFLEX WAS PERFORMED (STENTING). REASON FOR REVASC INSTENT RESTENOSIS. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS UNRELATED TO THE STUDY STENT.

    Description of Event or Problem · 1

    IT WAS CONFIRMED THAT THE STENTS IMPLANTED IN THE MID LCX AND LEFT MAIN WERE ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG-ELUTING STENTS AND NOT ENDEAVOR SPRINT RX STENTS AS INITIALLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0000659218

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization CLOPIDOGREL| ASPIRIN