It was reported that the flow diverting stent (subject device) was successfully implanted in the right internal carotid artery-ophthalmic (c6 segment).Three months post procedure it was observed in the mri that the complete right ophthalmic carotid artery was occluded.There were no symptoms, but there was subject flow diverting stent thrombosis.The issue was resolved and there was no treatment required.According to the site, this event had a causal relationship with the study device and underlying condition or disease.The event also had a probable relationship with the dapt.No additional information available.
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H4 manufacturing date ¿ added d4 expiration date ¿ added d4 lot # corrected - 22081695 to 22081695r.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that complete right ophthalmic carotid occlusion.Study device thrombosis or occlusion.The issue was resolved.Site reports that no action or treatment was given for the adverse event.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint of 'patient vessel thrombosis' and 'patient vessel occlusion'.
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It was reported that the flow diverting stent (subject device) was successfully implanted in the right internal carotid artery-ophthalmic (c6 segment).Three months post procedure it was observed in the mri that the complete right ophthalmic carotid artery was occluded.There were no symptoms, but there was subject flow diverting stent thrombosis.The issue was resolved and there was no treatment required.According to the site, this event had a causal relationship with the study device and underlying condition or disease.The event also had a probable relationship with the dapt.No additional information available.
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