BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3921547 · Received July 9, 2014

    Report

    Report Number
    9612164-2014-00746
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    December 6, 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

    SIX ENDEAVOR SPRINT DRUG ELUTING STENTS IMPLANTED DURING THE INDEX PROCEDURE, TWO IN THE CX AND FOUR IN THE LAD. AN ANGIOGRAPHIC COMPLICATION OF DISSECTION IS REPORTED TO HAVE OCCURRED DURING IMPLANT OF THE FOUR LAD STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402154 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0001028088

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization