Model Number 82090-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Paresis (1998); Nervous System Injury (2689); Thrombosis/Thrombus (4440)
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Event Date 01/20/2021 |
Event Type
Injury
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Manufacturer Narrative
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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 similar incidents reported from this lot.The reported patient effects of neurological complications and thrombosis are listed in the xact instructions for use as known potential patient effects potentially associated with carotid stents and embolic protection systems.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The additional non-surgical treatment (unexpected medical intervention) and medication was related to operational context.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Event Description
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It was reported that the procedure was performed to treat a lesion in the common carotid artery.An 8x40mm xact self-expanding stent system (sess) was used without issue.One hour after the procedure, the patient developed hemiparesis of the right limb, slurred speech, and thrombosis.Suction, thrombectomy, and thrombolysis were performed.Angiography confirmed that the thrombus in the stent was completely cleared and the blood flow in the stent was normal.Additionally, the hemiparesis and slurred speech were resolved.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
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Search Alerts/Recalls
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