BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE

    MDR report key: 3200911 · Received July 2, 2013

    Report

    Report Number
    9612164-2013-00685
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    January 29, 2013
    Report Date
    July 31, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (TVR). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (TVR). (B)(4).

    Description of Event or Problem · 1

    THREE COMPLETE SELF EXPANDING STENTS WERE IMPLANTED IN THE RIGHT LEG DURING THE INDEX PROCEDURE. APPROXIMATELY 7 MONTHS POST THE INDEX PROCEDURE, THE PATIENT WAS TREATED FOR IN-STENT RESTENOSIS WITH THREE IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETERS. THE FOLLOWING DAY A RE-OCCLUSION OF THE RIGHT SFA OCCURRED AND WAS TREATED WITH TWO BALLOONS ONE OF WHICH WAS A IN.PACT PACIFIC DEVICE. THE INVESTIGATOR HAS ASSESSED THAT THE OCCLUSION WAS DEFINITELY RELATED TO THE PROCEDURE AND NOT RELATED TO THE DEVICE. THE OUTCOME WAS RESOLVED.

    Description of Event or Problem · 1

    PATIENT ALSO WAS TREATED WITH ROTAREX DURING THE REVASCULARIZATION WHICH OCCURRED APPROXIMATELY 7 MONTHS POST IMPLANTATION OF THE COMPLETE SE STENTS. THE EVENT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301639 COMPLETE SE STENT, ILIAC NIO MEDTRONIC IRELAND 0006104685

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention ASPIRIN, CLOPIDOGREL