BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2231143 · Received August 26, 2011

    Report

    Report Number
    9612164-2011-01015
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    April 7, 2011
    Report Date
    August 2, 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). EVAL RESULTS: MYOCARDIAL INFARCTION.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE MID CIRCUMFLEX AND ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE PROXIMAL LAD. THE FOLLOWING DAY THE PT SUFFERED A MYOCARDIAL INFARCTION (MI). THE REPORTED MI WAS UNRELATED TO THE TARGET VESSEL. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS UNRELATED TO THE STUDY DEVICE. PT ASYMPTOMATIC AT 3 MONTHS F/U. (REF MFR# 9612164201101015 & 9612164201101016).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0003134629

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization THE PT WAS TAKING BETA BLOCKERS,| ASA AT TIME OF EVENT.| CLOPIDOGREL AND