BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2001374 · Received February 25, 2011

    Report

    Report Number
    9616099-2011-00133
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED INDICATED THAT SOMETIME AT THE END OF LAST YEAR (2010), SMART CONTROL STENTS (10MMX4CM/6CM) WERE PLACED IN THE SUPERIOR VENA CAVA, WHICH WAS OCCLUDED BY THE COMPRESSION OF A TUMOR. A FEW MONTHS LATER, INVASION OF THE TUMOR WAS OBSERVED AT THE STENTED AREA AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS CONDUCTED. THE APPROACH WAS MADE FROM THE RIGHT BRACHIAL VEIN. DILATATION AT THE TARGET LESION WAS CONDUCTED WITH A SLALOM THRILL AND A POWERFLEX P3, BUT COULD NOT DILATE THE DISTAL PART OF THE IMPLANTED STENT (INFERIOR VENA CAVA (IVC) SIDE). THEREFORE, A SMART CONTROL (C10060SL/LOT 15078332) WAS DELIVERED AND DEPLOYED TO PLACE OVER THE PREVIOUSLY IMPLANTED STENT (C10040SL) BUT THE STENT (LOT 15078332) WAS PLACED TOWARDS THE IVC. TO AVOID THE STENT FROM MIGRATING INTO THE RIGHT ATRIUM, AN ADDITIONAL (C10060SL/LOT 15286445) WAS DEPLOYED, BUT THE SAME THING HAPPENED. THEN, BOTH STENTS WERE PLACED IN THE RIGHT ATRIUM/VENTRICULAR. REMOVAL OF BOTH STENTS WAS CONDUCTED WITH A SNARE CATHETER AND FORCEPS FOR THE PERICARDIA. THE LOT # 15078332 STENT COULD NOT BE REMOVED FROM THE RIGHT ATRIUM/VENTRICULAR. THE LOT # 15286445 STENT WAS MOVED TO THE COMMON ILIAC VEIN AND IT WAS DECIDED TO LEAVE IT THERE. THE TARGET LESION HAD MILD CALCIFICATION AND VESSEL TORTUOSITY. THE RATE OF STENOSIS WAS 100%. THE STENT DELIVERY SYSTEM DID NOT PASS THROUGH ANY ACUTE BENDS. THERE WAS NO DIFFICULTY ENCOUNTERED WHILE ADVANCING/TRACKING THE SDS TOWARDS THE LESION. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. 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 THE SDS WAS ADVANCED PAST THE LESION AND THEN WITHDRAWN BACK INTO THE LESION PRIOR TO STENT DEPLOYMENT.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 IN THE IFU. THERE WAS NO UNUSUAL FORCE APPLIED DURING DEPLOYMENT OF THE STENT. THE PATIENT DID NOT SHOW ANY SYMPTOMS DURING THE PROCEDURE AND WAS IN STABLE CONDITION. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. THERE WAS NOTHING UNUSUAL NOTICED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. WHEN REMOVED FROM THE TRAY WAS THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. THIS IS ONE OF THREE PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 9616099-2011-00131, 9616099-2011-00132 AND 9616099-2011-00133.

    Additional Manufacturer Narrative · 1

    THE TARGET LESION HAD MILD CALCIFICATION AND VESSEL TORTUOSITY. THE RATE OF STENOSIS WAS 100%. THE STENT DELIVERY SYSTEM DID NOT PASS THROUGH ANY ACUTE BENDS. THERE WAS NO DIFFICULTY ENCOUNTERED WHILE ADVANCING/TRACKING THE SDS TOWARDS THE LESION. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. 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 IN THE IFU. THERE WAS NO UNUSUAL FORCE APPLIED DURING DEPLOYMENT OF THE STENT. THE PATIENT DID NOT SHOW ANY SYMPTOMS DURING THE PROCEDURE AND WAS IN STABLE CONDITION. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. THERE WAS NOTHING UNUSUAL NOTICED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. WHEN REMOVED FROM THE TRAY WAS THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH. THE DEVICE WAS IMPLANTED IN 2010. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THIS IS ONE OF THREE PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 9616099-2011-00131, 9616099-2011-00132 AND 9616099-2011-00133. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT SOMETIME (B)(6) 2010, SMART CONTROL STENTS (10MMX4CM/6CM) WERE PLACED IN THE SUPERIOR VENA CAVA, WHICH WAS OCCLUDED BY THE COMPRESSION OF A TUMOR. A FEW MONTHS LATER, INVASION OF THE TUMOR WAS OBSERVED AT THE STENTED AREA AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS CONDUCTED. THE APPROACH WAS MADE FROM THE RIGHT BRACHIAL VEIN. DILATATION AT THE TARGET LESION WAS CONDUCTED WITH A SLALOM THRILL (439-4040S) AND POWERFLEX P3 (420-0040S), BUT COULD NOT DILATE THE DISTAL PART OF THE IMPLANTED STENT (INFERIOR VENA CAVA (IVC) SIDE). THEREFORE, A SMART CONTROL (C10060SL/LOT 15078332) WAS DELIVERED AND DEPLOYED TO PLACE OVER THE PREVIOUSLY IMPLANTED STENT (C10040SL) BUT THE STENT (LOT 15078332) WAS PLACED TOWARDS THE IVC. TO AVOID THE STENT FROM MIGRATING INTO THE RIGHT ATRIUM, AN ADDITIONAL (C10060SL/LOT 15286445) WAS DEPLOYED, BUT THE SAME THING HAPPENED. THEN, BOTH STENTS WERE PLACED IN THE RIGHT ATRIUM/VENTRICULAR. REMOVAL OF THE STENTS WAS CONDUCTED WITH A SNARE CATHETER AND FORCEPS FOR THE PERICARDIA. THE LOT # 15078332 STENT COULD NOT BE REMOVED FROM THE RIGHT ATRIUM/VENTRICULAR. THE LOT # 15286445 STENT WAS MOVED TO THE COMMON ILIAC VEIN AND IT WAS DECIDED TO LEAVE IT IN THERE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention