After a guidewire crossed the lesion the smart control stent was delivered but resistance was felt.The stent was removed and it was confirmed that the distal tip part and the tip shaft part got frayed.There was no reported patient injury.There was no calcification confirmed.The patient¿s information is unknown.The target lesion was iliac artery.The patient¿s vessel level of tortuosity and calcification is unknown.The rate of stenosis is unknown.The product was stored and handled according to the instructions for use (ifu).There were no anomalies noted when the device was removed from the packaging.The product was inspected and prepped according to the ifu and the device prepped normally.The user held the handle of the smart control sds flat and straight outside the patient.The stent was replaced with another one of a different lot number.Additional procedural details were requested but are unknown.The product was not returned for analysis.A device history record (dhr) review of lot 17382568 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)-ses resistance/friction-outer sheath - in patient¿ 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, although generally unknown, or procedural and handling factors may have contributed to the reported event.According to the instructions for use ¿care should also be taken when deploying the stent as excessive force could, in rare instances, lead to stent deformation and/or fracture.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.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.¿ neither the device history record (dhr) review nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
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