BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1981917 · Received February 8, 2011

    Report

    Report Number
    9616099-2011-00089
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 20, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. WHEN REMOVED FROM THE TRAY, THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH. THE DIAMETER OF THE UNCONSTRAINED STENT SIZE WAS 1-2 MM LARGER THAN THE VESSEL DIAMETER. DELIVERY OF THE SDS TO THE LESION WAS CONTRALATERAL. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE WITH ANY OF THE TWO SES. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION. THE LOCKING PIN WAS REMOVED BEFORE ATTEMPTING TO DEPLOY THE SMART CONTROL STENT. THE SDS WAS ADVANCED PAST THE LESION AND THEN WITHDRAWN BACK INTO THE LESION PRIOR TO STENT DEPLOYMENT. THE HANDLE OF THE SMART CONTROL SDS WAS HELD FLAT AND STRAIGHT OUTSIDE THE PATIENT, AS INSTRUCTED BY THE IFU. THERE WAS NO UNUSUAL FORCE APPLIED DURING DEPLOYMENT OF THE STENT. THE TANTALUM MARKERS WERE OBSERVED TO OPEN SYMMETRICALLY. THE ADDITIONAL STENT FULLY EXPANDED WITH GOOD WALL APPOSITION. THE LESION WAS POST-DILATED AFTER THE 1ST STENT IMPLANTATION. IT IS UNKNOWN IF THE 2ND STENT WAS POST-DILATED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE CATALOG NUMBER IS UNKNOWN. ATTEMPTS TO OBTAIN THE DEVICE LOT NUMBER WERE MADE, BUT WERE UNSUCCESSFUL. THE COMPLAINT RECEIVED STATES THAT DURING AN INTERVENTIONAL PROCEDURE ONE SMART CONTROL STENT HAD INACCURATE PLACEMENT AND A SECOND FAILED TO CROSS THE TARGET LESION AND THE DISTAL TIP WAS DAMAGED WHILE IN THE PATIENT. DURING TREATMENT OF A 75% STENOSIS IN THE LEFT EXTERNAL ILIAC ARTERY, WITH HEAVY CALCIFICATION AND TORTUOSITY, A 7MM X 6CM SMART CONTROL STENT OF UNKNOWN CATALOG AND LOT NUMBER WAS DEPLOYED IN THE TARGET LESION, BUT THE STENT WAS NOT PLACED IN THE INTENDED POSITION AND ALSO WAS PLACED SHORTENED DUE TO THE HEAVILY TORTUOUS VESSEL. ANOTHER SMART CONTROL STENT OF THE SAME SIZE WAS DELIVERED, BUT THE STENT DELIVERY SYSTEM (SDS) WAS CAUGHT ON THE STENT AND FAILED TO CROSS THE LESION. THE SDS WAS REMOVED FROM THE PATIENT AND THE DISTAL TIP AND OUTER SHEATH WERE OBSERVED DAMAGED. THE STENT WAS RE-DILATED WITH A BALLOON CATHETER OF UNKNOWN BRAND AND ADDITIONAL STENT OF UNKNOWN BRAND WAS PLACED IN THE LESION WITHOUT PROBLEMS. THE LESION WAS FULLY COVERED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU AND INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. WHEN REMOVED FROM THE TRAY, THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH. THE DIAMETER OF THE UNCONSTRAINED STENT SIZE WAS 1-2 MM LARGER THAN THE VESSEL DIAMETER. DELIVERY OF THE SDS TO THE LESION WAS CONTRALATERAL. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE WITH ANY OF THE TWO SES. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION. THE LOCKING PIN WAS REMOVED BEFORE ATTEMPTING TO DEPLOY THE SMART CONTROL STENT. THE SDS WAS ADVANCED PAST THE LESION AND THEN WITHDRAWN BACK INTO THE LESION PRIOR TO STENT DEPLOYMENT. THE HANDLE OF THE SMART CONTROL SDS WAS HELD FLAT AND STRAIGHT OUTSIDE THE PATIENT, AS INSTRUCTED BY THE IFU. BOTH STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THERE IS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. THE COMPLAINT OF FAILURE TO CROSS AND TIP DAMAGED IN THE PATIENT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT FOR ANALYSIS. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. FAILURE TO CROSS USUALLY OCCURS IN CONJUNCTION WITH DEVICE SELECTION, VESSEL AND LESION CHARACTERISTICS AS WELL AS PRACTITIONER EXPERTISE. THE IFU RECOMMENDS THAT THE MOST DISTAL LESION BE TREATED FIRST THUS MINIMIZING THE NEED TO RE-CROSS IMPLANTED DEVICES WITH FURTHER EQUIPMENT. THE COMPLAINT OF INACCURATE PLACEMENT COULD NOT BE CONFIRMED WITHOUT PROCEDURAL FILMS FOR REVIEW; HOWEVER, THE SMART CONTROL: THE IFU (INSTRUCTIONS FOR USE) CAUTIONS "ADVANCE THE DELIVERY SYSTEM PAST THE LESION. PULL BACK THE DELIVERY SYSTEM UNTIL THE RADIOPAQUE STENT MARKERS (LEADING AND TRAILING ENDS) MOVE IN POSITION SO THAT THEY ARE PROXIMAL AND DISTAL TO THE LESION SITE. ENSURE THE DEVICE OUTSIDE THE PATIENT REMAINS FLAT AND STRAIGHT. CAUTION: SLACK IN THE CATHETER SHAFT EITHER OUTSIDE OR INSIDE THE PATIENT MAY RESULT IN DEPLOYING THE STENT BEYOND THE LESION SITE." REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL, LESION AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT DURING TREATMENT OF A 75% STENOSIS IN THE LEFT EXTERNAL ILIAC ARTERY, A 7MM X6CM SMART CONTROL STENT OF UNKNOWN CATALOG AND LOT NUMBER WAS DEPLOYED IN THE TARGET LESION, BUT THE STENT WAS NOT PLACED IN THE INTENDED POSITION AND ALSO WAS PLACED SHORTENED DUE TO THE HEAVILY TORTUOUS VESSEL. ANOTHER SMART CONTROL STENT OF THE SAME SIZE WAS DELIVERED, BUT THE STENT DELIVERY SYSTEM (SDS) WAS CAUGHT ON THE STENT AND FAILED TO CROSS THE LESION. THE SDS WAS REMOVED FROM THE PATIENT AND THE DISTAL TIP AND OUTER SHEATH WERE OBSERVED DAMAGED. THE STENT WAS RE-DILATED WITH A BALLOON CATHETER OF UNKNOWN BRAND AND ADDITIONAL STENT OF UNKNOWN BRAND WAS PLACED IN THE LESION WITHOUT PROBLEMS. THE LESION WAS FULLY COVERED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY. THE PRODUCT WILL NOT BE RETURNED. THE TARGET VESSEL HAD HEAVY CALCIFICATION AND TORTUOSITY. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU AND INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention