The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents.The investigation determined the cause for the reported difficulty to advance, difficulty to remove, delayed activation, and physical resistance are related to the circumstances of the procedure.It is likely that the tip or outer sheath of the supera system became stuck with a strut of the previously implanted stent during insertion.The act of pulling the system pulled the tip out allowing for normal operation and deployment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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