BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 3000029 · Received March 12, 2013

    Report

    Report Number
    9616099-2013-00140
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 17, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT'S INJURY REPORTED. PRODUCT WILL BE RETURNED FOR ANALYSIS. THE DEVICE APPEARED NORMAL BEFORE THE PROCEDURE. IT INSPECTED AND PREPPED PER IFU. IT IS LIKELY THAT THE BRITE TIP BECAME CRACKED DURING THE PROCEDURE, BECAUSE THE SMART CONTROL WAS BECAME CAUGHT AT THE EDGE OF THE SMART CONTROL ((B)(4)) WHILE IT WAS BEING DELIVERED TO THE LESION. CONCOMITANT MEDICAL PRODUCTS: INFLATION DEVICE: ABBOTT'S; GW: CHEVALIER30G, ASTATO, TREASURE, CRUISE; BC: SAVVY ((B)(4)), SAVVYLONG ((B)(4)); SHEATH: BRIITE TIP SHEATH ((B)(4)); STENT: SMART CONTROL ((B)(4)) ((B)(4)); MC: TRANSIT ((B)(4)). WHILE TRYING TO ADVANCE A SMART CONTROL STENT THROUGH A PREVIOUSLY DEPLOYED STENT IT BECAME CAUGHT AND THE PROXIMAL SHAFT KINKED. THE TARGET LESION WAS A HEAVILY CALCIFIED AND SLIGHTLY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY WITH A 100% STENOSIS. APPROACH WAS MADE FROM THE POPLITEAL ARTERY AND THE FEMORAL ARTERY. MULTIPLE WIRES AND CATHETERS WERE USED IN AN ATTEMPT TO CROSS THE LESION BEFORE PRE-DILATION WAS CONDUCTED ALLOWING FOR DEPLOYMENT OF 2 SMART CONTROL STENTS. THERE WAS NO PATIENT'S INJURY REPORTED. ANALYSIS OF THE RETURNED DEVICE SHOWED THAT THE DISTAL TIP WAS CRACKED. PER THE ACCOUNT IT IS LIKELY THAT THE BRITE TIP BECAME CRACKED DURING THE PROCEDURE, BECAUSE THE SECOND STENT BECAME CAUGHT AT THE EDGE OF THE FIRST SMART CONTROL STENT WHILE IT WAS BEING DELIVERED TO THE LESION. ONE NON-STERILE SMART CONTROL, ILIAC 7 X 40 MM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE LOCKING PIN WAS RECEIVED IN PLACE. KINKS WERE OBSERVED OUTER MEMBER/HYPOTUBE AT 2.5 CM FROM ID BAND AND IN THE DISTAL TIP. UNIT WAS NOT DEPLOYED AND THE BRITE TIP WAS CRACKED. NO OTHER DISCREPANCIES WERE FOUND. THE OUTER DIAMETER (OD) OF THE OUTER MEMBER WAS MEASURED AND IT WAS FOUND WITHIN SPECIFICATION. DURING THE MICROSCOPIC ANALYSIS, KINK WAS OBSERVED IN THE OUTER MEMBER AND CRACK WAS OBSERVED IN THE BRITE TIP. 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 FAILURE "SDS-KINKED IN PATIENT AND BRITE TIP CRACKED" REPORTED BY THE CUSTOMER WERE CONFIRMED. THESE CONDITIONS COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. HANDLING AND PROCEDURAL FACTORS COULD CONTRIBUTE TO THE FAILURE EXPERIENCED BY CUSTOMER. CONTROLS ARE IN PLACED AT THE FINAL ASSEMBLY AND PACKAGING PROCESSES TO DETECT THIS KIND OF ISSUES, THEREFORE NO ACTION WILL BE TAKEN. THE FAILURE "TRACKING DIFFICULTY-THROUGH ANOTHER STENT" REPORTED BY THE CUSTOMER WAS NOT CONFIRMED SINCE OUTER DIAMETER WAS FOUND WITHIN SPECIFICATION. THE EXACT CAUSE OF THE REPORTED FAILURE CONDITION COULD NOT BE CONCLUSIVELY DETERMINED. HANDLING AND PROCEDURAL FACTORS COULD BE CONTRIBUTED TO THE FAILURE EXPERIENCED BY CUSTOMER. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE FAILURE IS RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO ACTIONS WILL BE TAKEN. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED MAY HAVE BEEN CAUSED BY THE OPERATIONAL CONTEXT OF THE DEVICE, PROCEDURAL FACTORS OR VESSEL CHARACTERISTICS AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE.

    Description of Event or Problem · 1

    DURING PTA WITH STENTING A SMART CONTROL STENT BECAME CAUGHT AT THE EDGE OF A PREVIOUSLY DEPLOYED STENT AND THE PROXIMAL SHAFT KINKED. ANALYSIS OF THE DEVICE INDICATED THAT THE BRITE TIP WAS CRACKED. THE TARGET LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY. IT IS UNKNOWN IF THE LESION WAS A DE NOVO, BUT WAS HEAVILY CALCIFIED AND SLIGHTLY TORTUOUS. THERE WAS 100% STENOSIS (CTO), AND WAS 20 CM LONG. APPROACH WAS MADE FROM THE POPLITEAL ARTERY AND THE FEMORAL ARTERY. ANGIOGRAPHIC CATHETER (STR), MICRO CATHETER (TRANSIT, (B)(4)), AND 4 GUIDEWIRES (CHEVALIER 30 G, ASTATO, TREASURE, CROUSE) WERE USED TO CROSS THE LESION, AND CONSEQUENTLY ONLY THE GUIDEWIRE (ASTATO) ANTEROGRADELY CROSSED THE LESION FROM THE FEMORAL ARTERY. THE MICRO CATHETER (TRANSIT) WOULD NOT CROSS THE LESION OVER THE GUIDEWIRE (ASTATO), THEN, PRE-DILATION WAS CONDUCTED WITH A BALLOON CATHETER (SAVVY 2/40 MM 80 CM) TO CROSS THE MICRO CATHETER, AND THEN, 2 STENTS (SMART CONTROL C07100S X 2) WERE PLACED AT THE LESION. THEN, A 7 X 40 MM SMART CONTROL WAS DELIVERED TO COVER THE PROXIMAL PORTION OF THE LESION. THE PHYSICIAN SLIGHTLY PULLED THE SHEATH INTRODUCER TO ADVANCE THE SMART CONTROL TO THE LESION, BECAUSE THE DISTANCE BETWEEN THE PUNCTURE SITE AND DISTAL END OF THE SHEATH INTRODUCER AND THE LESION WAS CLOSE EACH OTHER. THE MICRO CATHETER WOULD NOT CROSS THE LESION, AND THE SMART CONTROL WAS BECAME CAUGHT AT THE EDGE OF THE SMART CONTROL ((B)(4)), BECAUSE PRE-DILATION WAS CONDUCTED WITH SMALL PRESSURE. HOWEVER, WHILE THE SMART CONTROL WAS BEING ADVANCED TO THE LESION, THE SHEATH INTRODUCER WAS WITHDRAWN WITHOUT INTENTION, AND THERE WAS DIFFICULTY RE-INSERTING THE SHEATH INTRODUCER INTO THE PATIENT. THEN, A KINK WAS CONFIRMED AT THE PROXIMAL SHAFT OF THE SMART CONTROL. THEN, THE PHYSICIAN STOPPED USING THE DEVICE AND A NEW SMART CONTROL ((B)(4)) WAS PLACED INSTEAD. POST DILATION WAS CONDUCTED WITH A BALLOON CATHETER ((B)(4)), AND THE PROCEDURE WAS FINISHED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104276 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO NA 15646777

    Patients

    Seq Age Sex Outcome Treatment
    1