As per sales rep, the 5x40mm precise pro rx self expanding stent (ses) was inserted into the patient and prior to deployment it was noticed that under fluoro the tip was flared.An image of the device was provided indicates premature deployment.The procedure was successfully completed with another stent.There was no patient injury.The intended procedure was a carotid stenting.The product was stored, handled, inspected and prepped according to the instructions for use.There was no difficulty during preparation of the device.There was difficulty inserting the ses into the sheath/into the patient because it had a flared tip.There was no excessive force used.An embolic protection device was used in the procedure.The device will be returned for analysis.
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A precise pro rx the 5x40mm self expanding stent (ses) was inserted into the patient and prior to deployment it was noticed that under fluoro the tip was flared.An image of the device was provided which indicates premature deployment.The procedure was successfully completed with another stent.The intended procedure was a carotid stenting.The product was stored, handled, inspected and prepped according to the instructions for use (ifu).There was no difficulty during preparation of the device.There was difficulty inserting the ses into the sheath/into the patient because it had a flared tip.There was no excessive force used.An embolic protection device was used in the procedure.There was no patient injury.The device was retuned for analysis.One non-sterile precise pro rx us carotid syst self expanding stent system was received for analysis inside a plastic bag.The valve of the precise pro rx was received tighten / closed.Per visual analysis, the stent of the unit was received 1.0 mm premature deployed.Also, the body shaft of the unit was received accordioned- like.Besides the previous mentioned conditions, no obvious defects or anomalies were found that could had contributed to the reported event.Per functional analysis, a deployment test was performed on the unit.The tuohy borst valve of the stent delivery system was opened, and the stent deployment test was successfully performed by retracting the outer sheath while holding the inner shaft in a fixed position.The stent was fully unsheathed/expanded as expected.No anomalies found.Per dimensional analysis, the usable length of the unit was measured, and it was found within specification.A product history record (phr) review of lot 18058440 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-deployment difficulty - premature/in patient - during advancement¿ was confirmed since the stent of the unit was received for analysis 1.0 cm pre deployed.However, the exact cause of the self-expanding stent system pre deployed condition could not be conclusively determined during the analysis.It can be suggested that procedural factors and/ or handling process may have contributed to the stent pre deployment condition of the unit the way it was received for evaluation.Analysis results and phr review results do not suggest that the observed pre-deployment condition is related to the manufacturing process.However, as stated by the customer ¿there was difficulty inserting the ses into the sheath/into the patient because it had a flared tip.¿ according to the instructions for use (ifu), ¿extract the stent delivery system from the tray.Examine the device for any damage.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.If a gap between the catheter tip and outer sheath tip exists, open the tuohy borst valve and gently pull the inner shaft in a proximal direction until the gap is closed.Lock the tuohy borst valve after the adjustment by rotating the proximal valve end in a clockwise direction.¿ neither the phr review nor the product analysis suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.
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