Investigation ¿ evaluation: a visual inspection of the returned device was performed.A review of complaint history, the device history record, quality control data, and specifications was also conducted.One open package labeled rpn 039712-r and lot number ns8314292 was received.One 6fr 26cm stent was received.The tether has been removed from the stent and it was not returned.The proximal coil was torn starting at the first side port and continued through the end of the stent.The braided tether for repositioning and removal of the device is located on the proximal pigtail of the stent.The tether has been pulled out of the stent causing the material to tear.A review of the device history record found there were no non-conformances noted.A review of complaint history revealed this complaint to be the only complaint associated with the complaint device lot number ns8314292.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Based on the information provided the definitive root cause is related to product use or handling.The product received excessive pressure.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
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