BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2900731 · Received January 8, 2013

    Report

    Report Number
    9612164-2013-00039
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    October 19, 2011
    Report Date
    June 18, 2014
    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

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION: 313 INHERENT RISK OF PROCEDURE ¿ (THROMBOSIS). (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THREE ENDEAVOR SPRINT STENTS WERE IMPLANTED, ONE IN THE LAD, ONE IN THE 1ST DIAGONAL BRANCH SEGMENT AND ONE IN THE L-AV. A MYOCARDIAL INFRACTION (MI) IS REPORTED TO HAVE OCCURRED THE SAME DAY AS THE INDEX PROCEDURE. THE INVESTIGATOR HAS INDICATED THE MI WAS RELATED TO THE TARGET VESSEL BUT UNRELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    AN ANGIOGRAPHIC COMPLICATION OF THROMBUS OCCURRED DURING THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9879 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005383942

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization ASPIRIN, CLOPIDOGREL