MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER
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Model Number NV UNK FLEX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Visual Disturbances (2140); Stenosis (2263)
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Event Date 04/25/2018 |
Event Type
Injury
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Manufacturer Narrative
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Wang t, richard sa, jiao h, li j, lin s, zhang c, wang c, xie x, you c.Institutional experience of in-stent stenosis after pipeline flow diverter implantation: a retrospective analysis of 6 isolated cases out of 118 patients.Medicine 2021;100:11(e25149) http://d x.Doi.Org/10.1097/md.0000000000025149.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.Refer to manufacturer report 2029214-2021-01108 for details pertaining to the related reportable event.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Wang t, richard sa, jiao h, li j, lin s, zhang c, wang c, xie x, you c.Institutional experience of in-stent stenosis after pipeline flow diverter implantation: a retrospective analysis of 6 isolated cases out of 118 patients.Medicine 2021;100:11(e25149) http://d x.Doi.Org/10.1097/md.0000000000025149.Medtronic literature review found reported of patient complications in association with implantation of the flex pipeline embolization device (pled).Wall malapposition was observed in 2 patients.The purpose of this article was to identify patients with, in-stent stenosis (iss) after implantations of pipeline flex embolization devices as treatments for intracranial aneurysms.They observed 5% (6/118) incidence rate of iss in intracranial aneurysmal patients treated with pleds at the institution.The patients were made up of 2 males and 4 females with a mean age of 42.The following intra- or post-procedural outcomes were noted: dizziness.Blurring of vision severe stenosis.Wall malapposition was observed in 2 patients, which occurred in the distal segments of the icas.
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