BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2120991 · Received June 13, 2011

    Report

    Report Number
    9616099-2011-00410
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE NON STERILE UNIT OF SMART 120/150 8X120 MM WAS RECEIVED COILED IN A PLASTIC BAG. OUTER SHEATH WAS BENT AT ID BAND. STENT WAS PARTIALLY DEPLOYED 1.5 CM. HEMOVALVE WAS CLOSED. NO OTHER DISCREPANCIES WERE FOUND. STENT DEPLOYMENT WAS COMPLETED WITH NO RESISTANCE FOUND. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE KINKED AND PARTIAL DEPLOYMENT CONDITIONS REPORTED BY THE CUSTOMER WERE CONFIRMED. THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. CONTROLS ARE IN PLACE AT THE FINAL ASSEMBLY AND PACKAGING PROCESSES TO PREVENT THIS TYPE OF FAILURE, SUCH AS (B)(4). PROCEDURAL FACTORS AND HANDLING CONDITION OF THE UNIT MAY CONTRIBUTE TO FAILURE AS REPORTED. NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE PRODUCT; THEREFORE, NO CORRECTIVE / PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, THIS MIGHT HAVE BEEN CAUSED DURING SHIPPING, STORAGE, OR HANDLING OF THE UNIT.

    Description of Event or Problem · 1

    AFTER UNPACKING THE BOX, STENT SHAFT WAS KINKED. WHEN THE PRODUCT WAS RETURNED IT WAS NOTED THAT THE STENT WAS PROTRUDING 1.5CM. THE SITE CONFIRMED THAT THIS WAS THE STATUS OF THE DEVICE PRIOR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA 15252052

    Patients

    Seq Age Sex Outcome Treatment
    1