It was reported that the procedure was performed to treat a lesion in the heavily calcified and tortuous right common carotid artery.The procedure was performed placing an emboshield nav6 embolic protection device at the target site.Pre dilatation was performed using a viatrac dilatation catheter.An acculink stent delivery system was advanced over a non-abbott guide wire, and deployed without issue.As standard procedure, post dilatation was performed using a non-abbott dilatation catheter.There were no adverse patient effects or device issues noted during the procedure.Later, on the evening of the procedure, the patient experienced breathing difficulty and resuscitation was performed.It was noted that a hematoma had occurred and was obstructing the patient's airway.It was thought that the hematoma had formed over a perforation that had occurred during the procedure, but was not noted.The hematoma resolved on its own, with no additional intervention required.The patient condition resolved.No additional information was provided.
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The device was not returned for evaluation.A review of the lot history record could not be conducted because the lot number was not provided.The reported patient effects of hematoma and perforation are listed in the rx acculink carotid stent system instructions for use (ifu) as possible adverse events associated with use of this device.A conclusive cause for the reported patient effects, 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.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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