BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3934587 · Received July 15, 2014

    Report

    Report Number
    9612164-2014-00952
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    September 5, 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

    RESULTS AND CONCLUSIONS: (DISSECTION). (B)(4).

    Description of Event or Problem · 1

    THREE ENDEAVOR SPRINT DRUG ELUTING STENTS WERE IMPLANTED DURING THE INDEX PROCEDURE; ONE IN THE CX AND TWO IN THE LAD. AN ANGIOGRAPHIC COMPLICATION OF DISSECTION OCCURRED IN THE LAD DURING THE INDEX PROCEDURE. THE EVENT WAS NOT ASSESSED FOR RELATEDNESS WITH THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412577 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005601250

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization