BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2041157 · Received March 29, 2011

    Report

    Report Number
    9612164-2011-00122
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 9, 2011
    Report Date
    March 4, 2011
    Manufacturer
    MEDTRONIC IRELAND
    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). EVALUATION: RESULTS: (MI).

    Description of Event or Problem · 1

    DUE TO STABLE ANGINA, THE PT UNDERWENT THE INDEX PROCEDURE WITH SUCCESSFUL DEPLOYMENT OF TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS TO THE PROXIMAL CIRCUMFLEX. APPROX 3 MONTHS POST INDEX PROCEDURE, THE PT EXPERIENCED A MYOCARDIAL INFARCTION (MI). THE PT WAS INTUBATED AND REC'D AN INTRA-AORTIC BALLOON PUMP (IABP). NO FURTHER DETAILS WERE PROVIDED. IN THE INVESTIGATOR'S OPINION, THE EVENT OF MYOCARDIAL INFARCTION WAS CONSIDERED SEVERE IN INTENSITY AND NOT RELATED TO STUDY MEDICATION, STUDY DEVICE OR STUDY PROCEDURE. (REF MFR # 9612164-2011-00121).

    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 48 YR CLOPIDOGREL| ASPIRIN