BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3931151 · Received July 14, 2014

    Report

    Report Number
    9612164-2014-00898
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    September 20, 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: (OCCLUSION, DISSECTION). (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE ONE ENDEAVOR SPRINT DRUG ELUTING STENT WAS IMPLANTED INTO THE RCA. A STAGED PROCEDURE WAS CARRIED OUT APPROXIMATELY 6 WEEKS LATER. ONE ENDEAVOR SPRINT STENT WAS IMPLANTED IN THE LEFT MAIN WITH THE SIDE BRANCH CX. ON THE SAME DAY ANOTHER ENDEAVOR SPRINT WAS IMPLANTED IN THE LAD (SIDE BRANCH/1ST DIAGONAL). AN ANGIOGRAPHIC COMPLICATION OF DISSECTION AND LATERAL BRANCH OCCLUSION OCCURRED DURING THIS STAGED PROCEDURE. IN ADDITION AN ANGIOGRAPHIC COMPLICATION OF ABRUPT VESSEL CLOSURE OCCURRED IN THE LAD (SIDE BRANCH/1ST DIAGONAL)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410728 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005639088

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR