The tip of the 6mm x100cm smart control iliac self-expanding stent delivery system (ses) was noted to be split after the device was removed from the patient.Additional information was received indicating that there was difficulty encountered while advancing/tracking the sds towards the lesion.The smart control iliac self-expanding stent delivery system (ses) was intended to be used during endovascular therapy (evt).The lesion was the iliac artery which had a chronic total occlusion (cto).There was unusual force used when the device crossed the lesion.There was severe vessel tortuosity noted and the percentage of stenosis was one hundred percent.The vessel had acute angulation and was severely calcified.The procedure was therefore completed by using another non-cordis device.There was no reported patient injury.There was no damage noted to the packaging of the device.There was nothing unusual noted about the stent delivery system prior to use.The device was stored and prepped as per the instruction for use.The device was not returned for analysis as it was discarded by the site.A product history record (phr) review of lot 17767489 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)- tracking difficulty¿ and ¿catheter tip- frayed/split/torn - in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of a 100% chronic total occlusion (cto), severe calcification, acute angulation and severe vessel tortuosity may have contributed to the reported event.According to the instructions for use, which are not intended as a mitigation of risk, "safety and effectiveness has not been demonstrated in: lesions that are either totally or densely calcified.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 re-positioning 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.Set the backer board 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.Perform an arterial angiogram to verify full deployment.If incomplete expansion exists within the stent at any point along the lesion, post deployment balloon dilatation can be performed at the discretion of the physician.Remove the balloon from the patient.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported burst; therefore, no corrective/preventive action will be taken at this time.
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