BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2160587 · Received July 6, 2011

    Report

    Report Number
    9612164-2011-00669
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    May 31, 2011
    Report Date
    September 4, 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). 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 MID RCA. THE FOLLOWING DAY, A MYOCARDIAL INFARCTION (MI) OCCURRED IN A NON TARGET VESSEL. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS UNRELATED TO THE STUDY DEVICE.

    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 45 YR Hospitalization ACE INHIBITOR| BETA-BLOCKER| CLOPIDOGREL| LIPID LOWERING DRUG| ASA, CLOPIDOGREL| NITRATE