BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1960873 · Received January 12, 2011

    Report

    Report Number
    2953200-2011-00073
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    October 6, 2010
    Report Date
    December 13, 2010
    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

    (B)(4): EVAL RESULTS: (STROKE).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PT HAD 3 ENDEAVOR SPRINT RX DRUG-ELUTING STENTS IMPLANTED IN THE PROXIMAL LCX (REF:MFR2953200-2011-00074, 2953200-2011-00075). IT WAS REPORTED THAT AT THE 30 DAY F/U THE PT HAD STABLE ANGINA. APPROX 2 MONTHS POST THE INDEX PROCEDURE THE PT HAD A PTCA TO TREAT A REVASCULARIZATION OF THE PROXIMAL AND MID RCA. THREE MORE ENDEAVOR SPRINT RX DRUG-ELUTING STENTS WERE IMPLANTED (REF: MFR2953200-2011-00076, 2953200-2011-00077, 2953200-2011-00078). AT THE 6 MONTH F/U THE PT WAS REPORTEDLY FREE OF SYMPTOMS. NO CLINICAL F/U WAS COMPLETED AT THE 1.5 YEAR F/U DUE TO THE PT'S HIGH WORK LOAD. THE PT WAS REPORTEDLY FREE OF SYMPTOMS AT THE 2 YEAR AND 2.5 YEAR F/U. IT WAS HOWEVER REPORTED THAT THE PT SUFFERED A STROKE APPROX 30 MONTHS POST THE INDEX PROCEDURE AND ANOTHER STROKE 3 DAYS POST THE FIRST STROKE. IT WAS CONFIRMED THAT THE STROKES WERE NOT RELATED TO THE STUDY STENT OR TO THE STUDY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000566138

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization EVENT.| THE PT HAS BEEN TAKING ASA 24 HOURS BEFORE THE| THE PT HAS BEEN TAKING CLOPIDOGREL 24 HOURS BEFORE| THE EVENT.