BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1143603 · Received August 26, 2008

    Report

    Report Number
    9616099-2008-02086
    Event Type
    Injury
    Date Received
    August 26, 2008
    Date of Event
    July 31, 2008
    Report Date
    July 31, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #'S: 9610978-2008-00219 AND 9616099-2008-02086.

    Description of Event or Problem · 1

    A MALE PATIENT WAS ADMITTED FOR STENTING OF A 90% STENOSIS IN THE COMMON-EXTERNAL ILIAC ARTERY. THERE WAS HEAVY CALCIFICATION AND MODERATE VESSEL TORTUOSITY. THE LESION WAS PRE-DILATED WITH A POWERFLEX P3, 5MM BALLOON A 7 X 8CM SMART STENT WAS PLACED WITHIN THE LESION AND WAS SUCCESSFULLY DEPLOYED. THE STENT WAS THEN POST DILATED WITH A POWERFLEX P3, 6MM X 4CM BALLOON INFLATED TO 10 ATMS. AFTER POST-DILATATION, A DISSECTION OCCURRED AT COMMON ILIAC ARTERY. ATTEMPTS TO TREAT THE DISSECTION WERE UNSUCCESSFUL AS THE PHYSICIAN WAS NOT ABLE TO GET ANY OTHER DEVICES TO CROSS THE SITE. THE PROCEDURE WAS FINISHED AT THAT POINT, WITHOUT ANY TREATMENT TO THE DISSECTION. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO NA 13269584

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R POWERFLEX BALLOON