BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3919086 · Received July 8, 2014

    Report

    Report Number
    9612164-2014-00731
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    September 13, 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).

    Description of Event or Problem · 1

    THREE ENDEAVOR SPRINT DRUG ELUTING STENTS WERE IMPLANTED DURING THE INDEX PROCEDURE; TWO IN THE R-PAV AND ONE IN THE RCA. AN ANGIOGRAPHIC COMPLICATION OF DISSECTION OCCURRED DURING IMPLANT OF TWO STENTS IN THE R-PAV AT THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397643 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005639088

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization