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.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.The reported patient effect of thrombosis is listed in the rx acculink carotid stent system instructions for use (ifu) as a possible adverse event associated with the use of this device.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that during preparation of the emboshield nav6 there was difficulty loading the filter into the delivery catheter.Therefore, the nav6 was not used in the procedure.There was no patient involvement with this device.An acculink was advanced to treat a lesion in the carotid artery.The stent was implanted successfully without issue.However, during post dilatation of the acculink thrombus was noted in the artery.Aspiration was performed and additional heparin was administered to treat the thrombus successfully.There was adverse patient sequela.No additional information was provided.
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