(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Visual inspection was performed on the returned device.The deployment issue was able to be confirmed as the stent was not returned.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 of the reported lot revealed no other incidents.The rx acculink instruction for use (ifu) states: the rx acculink carotid stent system, used in conjunction with the abbott vascular embolic protection system specified below, is indicated for the treatment of patients at high and standard risk for adverse events from carotid endarterectomy who require carotid revascularization.The investigation was unable to determine a cause for the reported difficulty.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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