(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.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 incidents from this lot.The investigation determined the reported difficulty to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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The procedure was to treat a lesion located in the internal carotid artery that was mildly tortuous, mildly calcified and 60% stenosed.During use of the emboshield nav6 embolic protection system, the filter slipped out of position when the patient became agitated and moved during the procedure.The retrieval device was used to retrieve the filter from the anatomy.A new filter and stent were used to complete the procedure.It was confirmed that the patient was stable the next day and this event did not result in an extension of the patient's stay.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.
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