BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2010390 · Received March 8, 2011

    Report

    Report Number
    9616099-2011-00165
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 14, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE STATES THAT THE DISTAL PART OF THE STENT WAS DISLODGED SO THE PHYSICIAN COULD NOT CROSS THE LESION WITH SMART STENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. ONE NON STERILE UNIT OF SMART CONTROL 7X40 MM WAS RECEIVED COILED IN A PLASTIC BAG ALONG WITH TWO DEPLOYED STENTS OF DIFFERENT LENGTHS (4.3 CM AND 2.1 CM). OUTER SHEATH WAS KINKED AND TORN AT 3.3 CM FROM ID BAND, AND BENT AT 1.4 CM FROM DISTAL END OF BRITE TIP. STENT AND LOCKING PIN WERE NOT IN PLACE. AT A GLANCE NO OTHER ANOMALIES WERE NOTED. THE DEPLOYMENT PROCESS WAS NOT PERFORMED DUE TO KINKED/TORN CONDITION OF THE OUTER SHEATH. REVIEW OF LOT REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PREMATURE DEPLOYMENT CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED DUE TO THE STENT WAS NOT IN PLACE. THE CAUSE OF THE KINKED/TORN AND BENT CONDITIONS COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THEY DO NOT APPEAR TO BE MANUFACTURING RELATED, CONTROLS EXIST IN THE MANUFACTURING PROCESS TO PREVENT AND DETECT THIS TYPE OF CONDITIONS. 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, IN THIS CASE, IT IS POSSIBLE THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER WAS RELATED TO PROCEDURAL FACTORS, VESSEL CHARACTERISTICS AND/OR USER HANDLING.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT TWO STENTS WERE RETURNED FOR EVALUATION ON (B)(6), 2011. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING AN INTERVENTIONAL PROCEDURE THE SMART CONTROL STENT HAD PREMATURE DEPLOYMENT. THE REPORT RECEIVED FROM THE AFFILIATE STATES THAT THE DISTAL PART OF THE STENT WAS DISLODGED (PKG ASSY 7X040 SMART VAS120CM) SO THE PHYSICIAN COULD NOT CROSS THE LESION WITH SMART STENT. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN SENT; HOWEVER, TO DATE NO FURTHER INFORMATION IS AVAILABLE. TO DATE THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS THE COMPLAINT COULD NOT BE CONFIRMED. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND THE DHR REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT BASED ON THE LIMITED INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE STATES THAT THE DISTAL PART OF THE STENT WAS DISLODGED (PKG ASSY 7X040 SMART VAS120CM) SO THE PHYSICIAN COULD NOT CROSS THE LESION WITH SMART STENT.

    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 15124317

    Patients

    Seq Age Sex Outcome Treatment
    1