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Model Number NV UNK PIPELINE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Ischemia (1942); Transient Ischemic Attack (2109); Rupture (2208); Stenosis (2263)
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Event Date 04/29/2021 |
Event Type
Injury
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Event Description
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Kang, h., luo, b., liu, j., zhang, h., li, t., song, d., zhao, y., guan, s., maimaitili, a., wang, y., feng, w., wang, y., wan, j., mao, g., shi, h., zhang, y., <(>&<)>amp; yang, x.(2021).Postoperative occlusion degree after flow-diverter placement with adjunctive coiling: analysis of complications.Journal of neurointerventional surgery.Https://doi.Org/10.1136/neurintsurg-2021-017445 summary: although coiling with a flow diverter may provide immediate dome protection, no studies have evaluated the effect on complications of postoperative occlusion degree immediately postoperatively.The purpose of this study was to determine whether postoperative occlusion degree immediately after flow-diverter placement with adjunctive coiling was associated with complications identified events: 1.51 patients experienced major ischemic stroke.44 patients were early post-operative and 7 patients were during the follow up period.2.34 patients experienced tia/minor stroke.30 patients were early post-operative and 4 were during the follow up period.3.24 patients had dar (delayed aneurysmal rupture.23 patients were early-operative and 1 was during the follow up period.4.23 patients had diph (distal intraparenchymal hemorrhage) during early-operative.5.114 patients had parent artery stenosis.54 patients were early-operative and 60 were during the follow up period.6.120 patients had mrs deterioratoin.85 patients were during early post-operative and 35 were during the follow up period.See attached literature article.
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Manufacturer Narrative
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Kang, h., luo, b., liu, j., zhang, h., li, t., song, d., zhao, y., guan, s., maimaitili, a., wang, y., feng, w., wang, y., wan, j., mao, g., shi, h., zhang, y., <(>&<)>amp; yang, x.(2021).Postoperative occlusion degree after flow-diverter placement with adjunctive coiling: analysis of complications.Journal of neurointerventional surgery.Https://doi.Org/10.1136/neurintsurg-2021-017445.This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.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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