BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2091816 · Received May 17, 2011

    Report

    Report Number
    9616099-2011-00339
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 21, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K042969
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED WHEN OPENING THE DEVICE, THE PHYSICIAN FOUND THAT AN ORANGE PIECE (WIRE LUMEN) WAS OUTSIDE OF THE DISTAL SHAFT. THE STENT WAS STORED AND HANDLED ACCORDING TO THE IFU. THE DEVICE WAS NOT USED ON THE PATIENT. WHEN THE PRODUCT WAS RECEIVED FOR ANALYSIS, THE DISTAL TIP OF INNER LUMEN WAS DETACHED AND NOT INCLUDED. ONE NON STERILE UNIT OF SMART 120/150 6X150 MM WAS RECEIVED COILED IN A PLASTIC BAG. OUTER SHEATH WAS KINKED AT ID BAND. STENT WAS IN PLACE. DISTAL TIP WAS NOT ATTACHED TO WIRE LUMEN AND IT WAS NOT RECEIVED. WIRE LUMEN WAS SENT FOR SEM ANALYSIS AND THE RESULT SHOW EVIDENCE OF ELONGATIONS CAN BE OBSERVED ON THE WIRE LUMEN SEPARATION SURFACE; ELONGATION IS A COMMON CHARACTERISTIC OF PIECES WHICH WERE STRETCHED/ PULLED UNTIL FAILURE. ABRASIONS CAN BE OBSERVED ON THE WIRE LUMEN. NO VISUAL EVIDENCE OF ANY CHEMICAL DEGRADATION WAS NOTED. CUTTING WAS DISCARDED AS A FAILURE CAUSE SINCE NO CHARACTERISTICS TYPICAL OF THIS FAILURE MODE WERE OBSERVED. 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 EXACT CAUSE OF THE SEPARATION REPORTED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER, IT DOES NOT APPEAR TO BE MANUFACTURING RELATED CONTROLS ARE IN PLACED AT THE FINAL ASSEMBLY AND PACKAGING PROCESSES TO PREVENT AND DETECT THIS TYPE OF FAILURE. THE CAUSE OF KINKED/BENT CONDITION COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED, CONTROLS ARE IN PLACED AT THE FINAL ASSEMBLY AND PACKAGING PROCESSES TO PREVENT THIS TYPE OF FAILURE, SUCH AS THE USE OF TRANSPORT RODS USED TO MAINTAIN THE SDS IN STRAIGHT POSITION TO PREVENT KINKS AND BENDS AS WELL AS THERE ARE INSPECTIONS IN PLACE TO DETECT DAMAGES IN THE SDS. 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 INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS RETURNED FOR TESTING AND EVALUATION BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY MARKETING AFFILIATE, WHEN OPENING THE DEVICE, THE PHYSICIAN FOUND THAT AN ORANGE PIECE (WIRE LUMEN) WAS OUTSIDE THE DISTAL SHAFT. THE ORANGE PIECE WAS NOT IN THE POSITION ON THE DISTAL SHAFT. THE STENT WAS STORED AND HANDLED ACCORDING TO THE IFU. THE DEVICE WILL BE SENT FOR INVESTIGATION. THE DEVICE WAS NOT USED ON THE PATIENT. WHEN THE PRODUCT WAS RECEIVED FOR ANALYSIS, THE DISTAL TIP OF INNER LUMEN WAS DETACHED AND NOT INCLUDED.

    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 15223120

    Patients

    Seq Age Sex Outcome Treatment
    1