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Model Number UNK-NV-MICROCATH |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Visual Disturbances (2140); Cognitive Changes (2551); Cramp(s) /Muscle Spasm(s) (4521)
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Event Date 07/14/2020 |
Event Type
Death
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Event Description
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Kulanthaivelu, k., pendharkar, h., prasad, c., kumar gupta, a., hanumanthapura ramalingaiah, a., saini, j., <(>&<)>amp; srinivas, d.(2020).Anterior cranial fossa dural arteriovenous fistulae ¿ angioarchitecture and intervention.Clinical neuroradiology, 31(3), 6 61¿669.Https://doi.Org/10.1007/s00062-020-00932-z summary: anterior cranial fossa (acf) dural arteriovenous fistulae (davf) are rare, unique, and ominous.While surgical disconnection is considered as the favored management option, endovascular treatment has latelygained importance.We present a single institution experience of seven cases.Identified event: a (b)(6) male had sudden onset swaying; 15 days back; giddiness; blurred vision.The angio result showed partial occlusion.An emergent decompressive hinge craniotomy was performed with ligation of the vein and evacuation of the hematoma.Following a decompressive craniotomy, the patient had fixed dilated pupils, with a glasgow coma scale (gcs) score of e1vtm1.Follow-up ct revealed multiple progressive hypodensities in the bilateral cerebral hemispheres, suggestive of infarcts due to vascular compression with ongoing mass effect.The patient died following a sudden cardiac arrest 5 days later.Devices used: neuronmax-navien-marathon co-axial system.
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Manufacturer Narrative
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Kulanthaivelu, k., pendharkar, h., prasad, c., kumar gupta, a., hanumanthapura ramalingaiah, a., saini, j., <(>&<)>amp; srinivas, d.(2020).Anterior cranial fossa dural arteriovenous fistulae ¿ angioarchitecture and intervention.Clinical neuroradiology, 31(3), 6 61¿669.Https://doi.Org/10.1007/s00062-020-00932-z.Please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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