SMART CONTROL

Description of Event or Problem

As reported, a 6F .035-inch 6mm x 60mm 120cm Smart Control stent could not allow passage of the 0.035 guidewire through the stent. There was no reported patient injury. The target lesion was the superficial femoral artery with severe calcification and mild tortuosity. The device was stored, handled, and prepared according to the Instructions for Use (IFU). During preparation, the 0.035-inch guidewire could not pass through the stent. The pouch temperature exposure indicator was checked and found acceptable. No abnormalities were noted with the stent delivery system prior to use, and the stent remained constrained within the outer sheath when removed from the tray. The unconstrained stent diameter was confirmed to be 1¿2 mm larger than the target vessel. No resistance or friction was encountered during insertion, and the stent delivery system did not pass through any acute bends. A contralateral approach was used. No difficulty was encountered while flushing the stent delivery system. The issue occurred outside the patient while advancing over the guidewire. A non-Cordis 0.035-inch guidewire was used. No difficulty was encountered advancing the stent delivery system over the guidewire. The difficulty occurred at the tip, and the guidewire could not be advanced into the catheter. Another Smart Control device were used to complete the procedure successfully without reported patient injury. The device will be returned for evaluation.Addendum: PE shows the tip of the outer sheath to be f/s/t.

Additional Manufacturer Narrative

Complaint Conclusion:As reported, a 6F .035-inch 6mm x 60mm 120cm Smart Control stent could not allow passage of the 0.035 guidewire through the stent. There was no reported patient injury. The target lesion was the superficial femoral artery with severe calcification and mild tortuosity. The device was stored, handled, and prepared according to the Instructions for Use (IFU). During preparation, the 0.035-inch guidewire could not pass through the stent. The pouch temperature exposure indicator was checked and found acceptable. No abnormalities were noted with the stent delivery system prior to use, and the stent remained constrained within the outer sheath when removed from the tray. The unconstrained stent diameter was confirmed to be 1¿2 mm larger than the target vessel. No resistance or friction was encountered during insertion, and the stent delivery system did not pass through any acute bends. A contralateral approach was used. No difficulty was encountered while flushing the stent delivery system. The issue occurred outside the patient while advancing over the guidewire. A non-Cordis 0.035-inch guidewire was used. No difficulty was encountered advancing the stent delivery system over the guidewire. The difficulty occurred at the tip, and the guidewire could not be advanced into the catheter. Another Smart Control device was used to complete the procedure successfully without reported patient injury. The device will be returned for evaluation.A non-sterile unit of ¿PKG ASSY 9X040 SMART VAS 80CM¿ was received for analysis inside of a plastic bag. The device was unpacked to perform the product evaluation. The unit was received separated into two pieces. However, review of the manage sample image did not show evidence of the observed separation. Only a kinked condition is observed. Therefore, the separation is considered to have occurred after the device was returned and is most likely attributable to decontamination and/or shipping activities. The stent is properly mounted on manufacturing position. The radiopaque distal marker is frayed. The locking tab was not returned. No other outstanding details were observed. Functional analysis was performed to determine if resistance/friction or obstruction between the wire lumen and the guide wire can be found at the insertion/withdrawal process. The wire lumen was flushing with water; a syringe filled with water was attached to the hub and positive pressure was applied until the water flowed out of the wire lumen by the separated end. Neither resistance nor loose material was observed during the flushing procedure. Insertion/withdrawal test was performed: A 0.035¿ lab sample guide wire was inserted and advanced all the way through the inner shaft of the two separated pieces. Then the guidewire was withdrawn completely from the inner shaft. Despite the separate condition, neither resistance nor friction were felt during the insertion/withdrawn test on both separated pieces.The edges of the frayed area on the radiopaque distal marker were inspected with a vision system observing that presented evidence of elongations and surface with ductile dimples. The elongation and surface with ductile dimples found on the material are commonly associated with damage caused by material tensile stress overload. Therefore, it is assumed that the outer sheath where the radiopaque distal marker is located was induced to a stress tensile force that exceeded the material yield strength prior to the frayed condition. No other outstanding details were observed during the evaluation.The ¿Guidewire Lumen (inner shaft) Obstructed particles/material cannot be injected¿ could not be verified during product evaluation. Functional testing demonstrated that a 0.035-inch guidewire could be advanced and withdrawn through the inner shaft without resistance or friction, and flushing of the guidewire lumen revealed no evidence of obstruction or loose material. Evaluation identified a frayed condition of the distal radiopaque marker; however, microscopic analysis showed features consistent with material tensile stress overload, indicating the damage resulted from an external tensile force exceeding the material yield strength rather than a manufacturing related condition. Based on the available information and product evaluation findings, the exact cause of the reported guidewire passage difficulty could not be determined. According to the instructions for use, which is not intended to mitigate risk, ¿Examine the device for any damage. If it is suspected that the sterility or performance of the device has been compromised, the device should not be used. d. Flush the flushing valve of the stent delivery system with saline using a 3-cc syringe to expel air. Continue to flush until saline weeps from the distal catheter end. e. Flush the guidewire lumen of the stent delivery system with saline using a 20-cc syringe to expel air. Continue to flush until the saline flows out of the wire lumen at the distal catheter tip. f. Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.¿ The information available nor product evaluation suggest a design or manufacturing related cause for the reported event. Therefore, no corrective or preventive action will be taken at this time.