BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE SFA

    MDR report key: 4205601 · Received October 28, 2014

    Report

    Report Number
    9612164-2014-01388
    Event Type
    Injury
    Date Received
    October 28, 2014
    Date of Event
    October 21, 2013
    Report Date
    October 25, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P110040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PREVIOUSLY THROMBOSIS WAS ALSO TREATED WITH A COMPLETE SE TWO DAYS LATER.

    Additional Manufacturer Narrative · 1

    EVALUATIO: INHERENT RISK OF PROCEDURE ¿ (STENT THROMBOSIS). (B)(4).

    Additional Manufacturer Narrative · 1

    THE CEC HAS ADJUDICATED THAT THE PREVIOUSLY REPORTED THROMBOSIS EVENT WAS RELATED TO THE STUDY DEVICE AND PROCEDURE, BUT WAS NOT RELATED TO PAXLITAXEL.

    Description of Event or Problem · 1

    PREVIOUSLY REPORTED RE-OCCLUSION EVENT HAS BEEN UPDATED AS ASSESSED BY THE INVESTIGATOR AS POSSIBLY RELATED TO THE PROCEDURE.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PHYSICIAN USED THREE IN. PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETERS TO TREAT A LESION LOCATED IN THE SFA OF THE RIGHT LEG. A COMPLETE SE STENT WAS ALSO IMPLANTED DUE TO RESIDUAL STENOSIS. AFTER THE DILATATION PROCEDURE ON ANGIOGRAPHY SHOWED A RE-OCCLUSION FROM THE RIGHT SFA, DUE TO THROMBUS. PATIENT WAS TREATED WITH THROMBOLYSIS. INVESTIGATOR HAS INDICATED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE OUTCOME IS REPORTED AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689964 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention