BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1030408 · Received April 16, 2008

    Report

    Report Number
    9616099-2008-01005
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 19, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    P020036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, AS OF TO DATE, THE EVAL HAS NOT BEEN COMPLETED. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, THE STENT DELIVERY SYSTEM (SDS) WAS DELIVERED TO THE LESION; HOWEVER, WHILE THE LOCKING PIN WAS IN PLACE, APPROX 1 CM OF THE STENT PREMATURELY DEPLOYED. SUBSEQUENTLY, THE STENT STRUTS OF SUCH SECTION WERE FRACTURED; THERE WAS NO SEPARATION .THE STENT WAS RECAPTURED WITHOUT ANY PROBLEMS AND WAS REMOVED ALONG WITH THE SDS. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING REMOVAL OF THE DEVICE. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO OTHER PROBLEMS ENCOUNTERED DURING THE PROCEDURE, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT. FURTHER INFO INDICATED THAT THE PRODUCT HAD BEEN INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WERE NO DIFFICULTIES ENCOUNTERED WHILE ADVANCING AND/OR TRACKING THE SDS TOWARD THE LESION. THERE WAS NO EXCESSIVE FORCE USED AT ANY TIME. THE INTENDED PROCEDURE INCLUDED TREATMENT OF A MILDLY TORTUOUS VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIQ) NIQ CORDIS DE MEXICO NA 13255682

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK