BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2172660 · Received July 20, 2011

    Report

    Report Number
    9612164-2011-00793
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 18, 2011
    Report Date
    December 10, 2012
    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): EVALUATION RESULTS: (MYOCARDIAL INFARCTION).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE PROXIMAL LAD AND DURING A STAGED PROCEDURE THREE WEEKS LATER THE PATIENT HAD ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE MID CIRCUMFLEX AND HAD ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE MID RCA. THE DAY AFTER THE STAGED PROCEDURE, THE PATIENT SUFFERED AN MI. IT IS UNKNOWN WHETHER THE MI WAS RELATED TO THE TARGET VESSEL. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS UNLIKELY RELATED TO THE DEVICE. (REF MFR #9612164-2011-00794 AND 9612164-2011-00795).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0002947371

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization THE PATIENT WAS TAKING BETA-BLOCKERS,| CLOPIDOGREL AND| CA++ ANTAGONIST,| ASA AT TIME OF EVENT.