During a carotid artery stenting (cas) case, an 8x40mm precise pro rxself expanding stent was implanted but an unknown filter wire got stuck on the strut of the stent.It was unable to cover the lesion therefore, a non-cordis stent was implanted, ¿covering the strut part.¿ the procedure completed.There was no reported patient injury.The sales rep cannot visit the hospital because of the covid-19.Therefore, additional information cannot be obtained.The device will not be returned because it was implanted.
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During a carotid artery stenting (cas) case, an 8x40mm precise pro rx self expanding stent was implanted but an unknown filter wire got stuck on the strut of the stent.It was unable to cover the lesion therefore, a non-cordis stent was implanted, ¿covering the strut part.¿ the procedure completed.The sales rep cannot visit the hospital because of the covid-19.Therefore, additional information cannot be obtained.There was no reported patient injury.The device was not returned because it was implanted.A product history record (phr) review of lot 18042555 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis and based on the information provided, the reported ¿stent-ses~ migration¿ was not confirmed.It is difficult to draw a clinical conclusion between the device and the event based on the information available.However, it is probable to consider that the user¿s interaction with the device and the ¿unknown filter wire¿ as well as vessel characteristics (although unknown) may have contributed to the reported event.According to the instructions for use (ifu) ¿if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit.(do not remove guidewire.) neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.
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