It was reported that this was a procedure performed to treat a target lesion in the moderately calcified right common carotid artery ostium.A non-abbott embolic protection device filter and wire were placed at the target site and pre-dilatation was performed.The omnilink stent was advanced and deployed without issue.Post dilatation was performed and the non-abbott filter retrieval catheter was advanced.Resistance was noted advancing the retrieval catheter and the catheter caught on the edge of the omnilink stent.The filter wire advanced into the stent and the physician tried manipulating the retrieval catheter to remove it; however, the filter popped into the stent and the filter wire snapped.The filter remained caught in the omnilink stent and was unable to be retrieved.The stent was noted to be damaged, as a result of the interaction with the retrieval catheter, and moved a small amount into the aorta.The patient was sent for a surgical procedure to remove the non-abbott filter.The decision was made to leave the omnilink stent in place, as there was concern of causing more damage.A surgical bypass procedure was performed, from the aorta to the common carotid artery, above the stent.Post procedure, the patient is in stable condition.No additional information was provided.
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents.The investigation determined the reported difficulties and surgical intervention appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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