BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1933850 · Received December 9, 2010

    Report

    Report Number
    2953200-2010-02496
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    September 20, 2010
    Report Date
    November 11, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: MYOCARDIAL INFARCTION.

    Description of Event or Problem · 1

    THE PT UNDERWENT THE INDEX PROCEDURE WITH DEPLOYMENT OF ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT TO THE THIRD OBTUSE MARGINAL. POST STENT DEPLOYMENT RESIDUAL STENOSIS WAS 0% WITH TIMI III FLOW. THE PT RECEIVED A PERI-PROCEDURAL LOADING DOSE OF STUDY MEDICATION CLOPIDOGREL, 300 MG AND ALSO BEGAN ASPIRIN 325 MG DOSING. THE FOLLOWING DAY THE PT BEGAN 75 MG CLOPIDOGREL DOSING. THE PT WAS DISCHARGED FROM THE INDEX PROCEDURE HOSPITALIZATION. DURING A 6 MONTHS FOLLOW CALL, THE PT REPORTED BEING HOSPITALIZED AT AN OUTLYING HOSPITAL. APPROXIMATELY 5.5 MONTHS POST INDEX PROCEDURE, THE PT WAS ADMITTED WITH CHEST PAIN AND A NON ST ELEVATION MI. THE CARDIAC ENZYMES WERE REPORTED AS POSITIVE. THE PT WAS FOUND TO BE POSITIVE FOR COCAINE USE. NO CARDIAC CATHETERIZATION WAS PERFORMED. THE DIAGNOSIS OF A POSSIBLE SUBENDOCARDIAL MYOCARDIAL INFARCT WAS MADE. THIS EVENT WAS REPORTED DUE TO BEING A SERIOUS EVENT REQUIRING PT HOSPITALIZATION. IN THE OPINION OF THE INVESTIGATOR, THE NON ST ELEVATION MI WAS SEVERE IN INTENSITY, NOT RELATED TO THE STUDY DRUG, NOT RELATED TO THE STUDY DEVICE, AND NOT RELATED 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization