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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/01/2020 |
Event Type
Death
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Manufacturer Narrative
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Ho jun yi, jae hoon sung, dong hoon lee, seung yoon song.Effectiveness and technical considerations of solitaire platinum 4x40 mm stent retriever in mechanical thrombectomy with solumbra technique.Journal of korean neurosurgical society.2021;64(1):30-38.Doi:10.3340/jkns.2020.0046.Age or date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Date of event: please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Ho jun yi, jae hoon sung, dong hoon lee, seung yoon song.Effectiveness and technical considerations of solitaire platinum 4x40 mm stent retriever in mechanical thrombectomy with solumbra technique.Journal of korean neurosurgical society.2021;64(1):30-38.Doi:10.3340/jkns.2020.0046.Medtronic literature review found reported of patient complications in association with solitaire thrombectomy.The purpose of this article was evaluate the effect of solitaire platinum 4×40 mm stent retriever in solumbra technique thrombectomy (stent retriever with simultaneous aspiration), and compare it with shorter solitaire stent retrievers with equal diameter (4 mm) and different length (40 vs.20 mm) solitaire stent retrievers: the solitaire platinum 4×40 mm stent (4×40) and the solitaire fr 4×20 mm stent or solitaire platinum 4×20 mm stent.The authors reviewed 70 cases of patients who underwent solumbra technique thrombectomy.Of the 70 patients, the average age was 70 years, 29 were female and 41 were male.The article does not state any technical issues during use of the solitaire.The following intra- or post-procedural outcomes were noted for the 4x20 solitaire: the 3 month mortality included 4 patients.Refer to manufacturer report 2029214-2021-00220 for details pertaining to the related reportable event.
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Search Alerts/Recalls
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