BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3924885 · Received July 10, 2014

    Report

    Report Number
    9612164-2014-00792
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    October 15, 2010
    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).

    Description of Event or Problem · 1

    THREE ENDEAVOR SPRINT DRUG ELUTING STENTS WERE IMPLANTED DURING THE INDEX PROCEDURE; TWO IN THE LAD, ONE IN THE 1ST DIAG. AN ANGIOGRAPHIC COMPLICATION OF DISSECTION OCCURRED DURING THE INDEX PROCEDURE, DURING TREATMENT OF THE LAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402785 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0000932565

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Hospitalization