BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE SFA

    MDR report key: 5146740 · Received October 14, 2015

    Report

    Report Number
    9612164-2015-01634
    Event Type
    Injury
    Date Received
    October 14, 2015
    Date of Event
    January 5, 2015
    Report Date
    April 14, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P110040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE OCCLUSION OF THE LEFT SFA EVENT THAT OCCURRED APPROXIMATELY 22 MONTHS POST INDEX PROCEDURE WAS TREATED WITH NON MEDTRONIC DEB AND STENTING.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THREE IN.PACT ADMIRAL PACLITAXEL ELUTING BALLOON CATHETERS WERE USED DURING INDEX PROCEDURE IN THE LEFT SFA (L-1). A COMPLETE SE STENT WAS ALSO IMPLANTED TO TREAT A DISSECTION ON THE SAME DATE. APPROXIMATELY 22 MONTHS POST INDEX PROCEDURE OCCLUSION OF THE LEFT SFA OCCURRED (L-1) WITH RECANALISATION AND REVASC OF THE LESION USING NON-MDT PTA AND STENT. INVESTIGATOR ASSESSED THAT THE EVENT IS PROBABLY RELATED TO THE STUDY DEVICE BUT NOT RELATED TO THE PROCEDURE OR PACLITAXEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680075 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention