BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3062511 · Received April 17, 2013

    Report

    Report Number
    9612164-2013-00428
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    February 17, 2012
    Report Date
    March 28, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE - (MYOCARDIAL INFARCTION). (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO EACH OF THE FOLLOWING MID RCA,1ST OBTUSE AND 2ND OBTUSE MARGINAL. THE FOLLOWING DAY THE PATIENT SUFFERED A MYOCARDIAL INFARCTION (MI). IT IS UNKNOWN WHETHER THE REPORTED MI WAS RELATED TO THE 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
    164350 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0002379217

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization CLOPIDOGREL AND ASPIRIN.