BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3922581 · Received July 9, 2014

    Report

    Report Number
    9612164-2014-00768
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    November 19, 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

    DURING THE INDEX PROCEDURE, THE PATIENT HAD AN ENDEAVOR SPRINT DRUG ELUTING STENT IMPLANTED IN THE LAD. SEVEN DAYS LATER, THE PATIENT UNDERWENT A STAGED PROCEDURE WITH 2 ENDEAVOR SPRINT STENTS BEING IMPLANTED INTO THE CX. AN ANGIOGRAPHIC COMPLICATION OF DISSECTION OCCURRED DURING THIS STAGED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401534 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0001139863

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Hospitalization