BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2230621 · Received August 11, 2011

    Report

    Report Number
    9612164-2011-00918
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD ON ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS IMPLANTED TO THE PROXIMAL CIRCUMFLEX. THE FOLLOWING DAY THE PATIENT SUFFERED A MYOCARDIAL INFARCTION (MI). THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS POSSIBLY RELATED TO THE STUDY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0002833292

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization ACE| CLOPIDOGREL| LIPID LOWERING DRUGS| THE PATIENT WAS TAKING BETA-BLOCKERS| ASA AT TIME OF REPORTED EVENT