BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SSYTEM

    MDR report key: 1140113 · Received August 28, 2008

    Report

    Report Number
    9616099-2008-02112
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 4, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. REVIEW OF LOT 13244360 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ZERO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE, IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER. THERE ARE PROCEDURAL FACTORS; SPECIFICALLY THE RESISTANCE DURING TRACKING THAT MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVED STATES, THE SMART CONTROL STENT HAD DIFFICULTY IN DEPLOYMENT AND THE STENT WAS INACCURATELY PLACED. THE PATIENT WAS MALE OF UNKNOWN AGE AND MEDICAL HISTORY. THE TARGET LESION WAS SFA (SUPERFICIAL FEMORAL ARTERY). THERE WAS NO LESION CHARACTERISTICS PROVIDED. IT WAS INDICATED THAT THE PRODUCT WAS STORED, INSPECTED, PREPED, AND HANDLED ACCORDING TO THE IFU (INSTRUCTIONS FOR USE). PRIOR TO USE, NOTHING UNUSUAL WAS NOTED ABOUT THE STENT DELIVERY SYSTEM. THE LESION WAS PRE-DILATED PRIOR TO STENT IMPLANTATION. DURING ADVANCEMENT TOWARDS THE LESION, THE SMART CONTROL LOCKING PIN WAS IN PLACE, AND THE PIN WAS NOT REMOVED BEFORE ATTEMPTING TO DEPLOY THE SMART CONTROL STENT. PRIOR TO STENT DEPLOYMENT, THE (SDS) STENT DELIVERY SYSTEM WAS ADVANCED PAST THE LESION AND THEN WITHDRAWN BACK INTO THE LESION. THE IFU INSTRUCTS THE USER TO HOLD THE HANDLE OF THE SMART CONTROL SDS FLAT AND STRAIGHT OUTSIDE THE PATIENT, WHICH WAS DONE BY THE USER. THERE WAS NOTED RESISTANCE WHEN THE DEVICE WAS TRACKED TO THE LESION, AND DURING THE DELIVERY, THE PHYSICIAN FELT LIKE IT "PUSHED OUT". UNUSUAL FORCE WAS NOT APPLIED DURING DEPLOYMENT OF THE STENT. A SECOND STENT (UNKNOWN) WAS PLACED TO COVER THE REMAINING PORTION OF THE LESION AND THE ENTIRE LESION WAS POST DILATED WITH ACCEPTABLE RESULTS. THERE WAS NO REPORTED INJURY FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SSYTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO NA 13244360

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention SECOND UNKNOWN BRAND STENT