STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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Model Number M0035467200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Visual Impairment (2138); Cognitive Changes (2551)
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Event Date 12/10/2021 |
Event Type
Injury
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Event Description
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It was reported in a clinical trial procedure to treat a right posterior communicating artery aneurysm, the patient had hemianopia and delirium.On imaging, occipital micro embolic infarcts were seen which resulted in prolonged hospitalization for the patient.The event was treated with physiotherapy and oral olanzapin 5 mg for delirium for 5 days and recovered.In the physician's opinion, the event was possibly related to the subject device and other stryker devices used in the procedure.
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Manufacturer Narrative
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Device is implanted in patient.
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Event Description
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It was reported in a clinical trial procedure to treat a right posterior communicating artery aneurysm, the patient had hemianopia and delirium.On imaging, occipital micro embolic infarcts were seen which resulted in prolonged hospitalization for the patient.The event was treated with physiotherapy and oral olanzapin 5 mg for delirium for 5 days and recovered.In the physician's opinion, the event was possibly related to the subject device and other stryker devices used in the procedure.
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Manufacturer Narrative
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H4 manufacturing date ¿ added.D4 expiration date - added.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 in a clinical trial, the patient had hemianopia and delirium post procedure with the subject coil.The ae was treated with physiotherapy and oral olanzapin 5 mg for delirium for 5 days.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.H3 other text : device is implanted in patient.
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Search Alerts/Recalls
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