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A review of the manufacturing documentation associated with lot 334712 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
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As reported, the 5x100 smart flex stent deployment is no longer stretched.It was noted that only the proximal part of the stent deployed.The stent did not work after that was noticed.When pulled strongly, the sheath and hub connections separated.The device was removed while the stent was spread, after dissection and acute occlusion.The case was completed with a new unknown non-cordis stent.The patient is scheduled for amputation.The product was stored and handled per the ifu.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background is clearly visible.The stent was still constrained within the outer member/sheath when removed from the tray.There was no difficulty encountered while flushing the sds.The target lesion was in a superficial femoral artery.An unknown 8fr sheath was used with an unknown.035 guidewire.An unknown 8fr guiding catheter was used.The diameter of the unconstrained stent size was 1 to 2mm larger than vessel diameter.The vessel length was 100mm.The lesion was noted to have a 50% stenosis.The lesion did not have any calcification and the vessel was not torturous.The stent delivery system did not pass through any acute bends.There was no difficulty encountered while advancing the system towards the lesion.There was no thrombus at the legion site due to thrombectomy prior to stent.The sds was not advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The device will be returned for evaluation.
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As reported, the 5x100 smart flex stent deployment is no longer stretched.It was noted that only the proximal part of the stent deployed.The stent did not work after that was noticed.When pulled strongly, the sheath and hub connections separated.The device was removed while the stent was spread, after dissection and acute occlusion.The case was completed with a new unknown non-cordis stent.The patient is scheduled for amputation.The product was stored and handled per the ifu.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background is clearly visible.The stent was still constrained within the outer member/sheath when removed from the tray.There was no difficulty encountered while flushing the sds.The target lesion was in a superficial femoral artery.An unknown 8fr sheath was used with an unknown.035 guidewire.An unknown 8fr guiding catheter was used.The diameter of the unconstrained stent size was 1 to 2mm larger than vessel diameter.The vessel length was 100mm.The lesion was noted to have a 50% stenosis.The lesion did not have any calcification and the vessel was not torturous.The stent delivery system did not pass through any acute bends.There was no difficulty encountered while advancing the system towards the lesion.There was no thrombus at the legion site due to thrombectomy prior to stent.The sds was not advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The device was returned for analysis.A non-sterile ¿smart flex 5x100 vas, 120cm¿ was received coiled inside of a clear plastic bag.The device was unpacked and was laid flat on a tray to proceed with the product evaluation.The unit was returned fully deployed.The stent was returned for analysis and no damages were noted on it.The hemostasis valve is open.Several kinks were noticed located at approximately 121 and 122cm from the distal tip.An outer sheath separation is observed located at approximately 128 cm from the distal tip.No other damages or anomalies were observed on the returned device.Dimensional analysis was performed to identify the measurement of the kinked and separated condition.Functional testing was not performed due to the separated condition on the outer sheath and the unit being returned fully deployed.Sem analysis was not performed because the damages associated with the separation are visible with the magnification obtained with a vision system.Results showed that the edges on the separated area presented evidence of elongations.The elongations found on the plastic material and the plastic deformation are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the material was induced to a tensile force that exceeded the yield strength prior to the separation.A product history record (phr) review of lot 334712 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds) deployment difficulty-partial deployment¿ was not confirmed as the stent was received fully deployed and due to the nature of the complaint, cannot be replicated in a lab setting.The reported ¿outer sheath separated¿ was confirmed due to the separated condition as recieved on the outer sheath.Additionally, a kinked condition was found on the body of the device.Device analysis concludes the device was induced to events that exceeded its material yield strength prior to the separation of the outer sheath.Therefore, based on the information available for review it is like handling and procedural factors contributed to the events reported by the customer.According to the instructions for use, which is not intended as a mitigation, ¿if resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to stent or system.If resistance occurs during movement through the sheath, carefully withdraw the stent system.Once stent deployment has begun, the stent must be fully deployed.The system is not designed for stent repositioning or recapturing.If resistance is felt when initially retracting the outer deployment sheath, do not force deployment.Carefully withdraw the stent system without deploying the stent.Prepare stent delivery system: open the outer box to reveal the pouch containing the stent and delivery catheter.After careful inspection of the pouch, looking for damage to the sterile barrier, carefully peel open the outer pouch and extract the inner pouch.Carefully peel open the inner pouch and remove the backerboard with carrier tube which holds the stent delivery system.Warning: do not use if pouch is opened or damaged.Set the backerboard with carrier tube on a flat surface.Remove the stent/delivery system from the carrier tube.Examine the device for damage.If it is suspected that the sterility has been compromised or the device is damaged do not use the device.If the distal tip (8) is not seated in the outer sheath (1), loosen the tuohy borst valve (5) on the handle (3) and retract the pusher tube (2) such that the distal tip (8) will seat in the outer sheath (1).Tighten the tuohy borst valve by rotating the valve hub clockwise.Check to ensure that the touhy borst valve (5) on the handle is tightened on the pusher tube (2).Use a 1-3 cc syringe to flush the outer sheath (1) with sterile heparinized saline through the female luer (4) on the handle.Flush until only a few drops of saline exit the distal end of the outer sheath.Complete system flushing may require 2-3 flushings with a 1cc syringe.Warning: if the outer sheath (1) cannot be flushed do not use the device.Use a 3-10 cc syringe to flush the inner lumen of the guidewire tube with sterile heparinized saline through the proximal luer hub (6) attached to the pusher tube (2), until saline flows out of the guidewire lumen at the distal tip.Warning: if the inner lumen of the guidewire tube (7) cannot be flushed do not use the device.Introduce the stent delivery system: advance the device over the guidewire and through the introducer to the target site.If resistance is met during delivery system introduction, the system should be withdrawn and another system used.Under fluoroscopic guidance, position the distal stent markers (10) distal to the target lesion and proximal placement marker (12) proximal to the target lesion.Straighten the proximal part of the delivery system as much as possible and keep the handle in a stable position.The tuohy borst valve (5) on the handle (3) must be loosened to allow free movement of the pusher tube (2).¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.
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As reported, the 5x100 smart flex stent deployment is no longer stretched.It was noted that only the proximal part of the stent deployed.The stent did not work after that was noticed.When pulled strongly, the sheath and hub connections separated.The device was removed while the stent was spread, after dissection and acute occlusion.The case was completed with a new unknown non-cordis stent.The patient is scheduled for amputation.The product was stored and handled per the ifu.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background is clearly visible.The stent was still constrained within the outer member/sheath when removed from the tray.There was no difficulty encountered while flushing the sds.The target lesion was in a superficial femoral artery.An unknown 8fr sheath was used with an unknown.035 guidewire.An unknown 8fr guiding catheter was used.The diameter of the unconstrained stent size was 1 to 2mm larger than vessel diameter.The vessel length was 100mm.The lesion was noted to have a 50% stenosis.The lesion did not have any calcification and the vessel was not torturous.The stent delivery system did not pass through any acute bends.There was no difficulty encountered while advancing the system towards the lesion.There was no thrombus at the legion site due to thrombectomy prior to stent.The sds was not advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The device will be returned for evaluation.
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