Catalog Number XRX04009T |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Thrombosis (2100)
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Event Date 01/03/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was performed to treat an 85% stenosed, moderately tortuous, and heavily calcified lesion in the left inner carotid artery.A 40x9-7mm x-act freestyle stent was deployed; however, the patient suffered a stroke some hours later.An angiogram was performed and thrombosis in the stent was confirmed.The patient was treated with antiplatelet therapy and was discharged home.No additional information was provided.
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Event Description
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Subsequent to the previously filed report, additional information was received: the patient did not suffer a stoke.The patient was transferred to another hospital and unspecified treatment was performed.No additional information was provided.
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Manufacturer Narrative
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Internal file number - (b)(4).Corrections: outcomes attributed to adverse event: the patient did not suffer a disability or permanent damage.Patient code 1770 was removed.The device was not returned for evaluation.The reported patient effect of thrombosis is listed in the xact instructions for use, as a known possible complication associated with carotid stenting procedures.A review of the lot history record and corrective action tracking system for the web revealed no exceptions associated with this lot.Based on the case information and related record review, a conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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