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Model Number UNK-NV-REBAR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Thromboembolism (2654)
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Event Date 09/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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Cem bilgin, yavuz durmus, cemile haki, omer fatih nas, bahattin hakyemez.Direct aspiration thrombectomy experience with the sofia 6f catheter in acute ischemic stroke.Japanese journal of radiology.2021;39:605¿610.Https://doi.Org/10.1007/s11604-021-01090-z. refer to regulatory rep #: 2029214-2022-01117 for related event information.64 years is the average age of the patients who used solitaire devices in the study.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Cem bilgin, yavuz durmus, cemile haki, omer fatih nas, bahattin hakyemez.Direct aspiration thrombectomy experience with the sofia 6f catheter in acute ischemic stroke.Japanese journal of radiology.2021;39:605¿610.Https://doi.Org/10.1007/s11604-021-01090-z.The purpose of this article was to evaluate the usefulness of the sofia 6f catheter in mechanical thrombectomy with the direct aspiration first pass technique.There were 148 patients, 67 were female and 81 were male.The average age was 64 years.The rate of complete recanalization (tici 3) was 36.9% with direct aspiration and 52.7% in all cases.The median nihss score on discharge was 4 (iqr 2¿10.5).The rate of patients with an mrs score of 0¿2 at 90 days was 49.3%.Thromboembolic complications in new territories occurred in 8 cases.After treatment, a symptomatic intracranial hemorrhage (sich) that increased the nihss score by 4 points or more within 24 h was observed in 8 patients.In three cases, intracranial dissection was detected after the use of the stent retriever.There was no complication directly related to the sofia 6f catheter.The mortality rate after the procedure was 14.1%.The following intra- or post-procedural outcomes related to the medtronic pipeline were noted: mortality, symptomatic intracranial hemorrhage, thrombolysis in cerebral infarction, thromboembolic complications.
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Search Alerts/Recalls
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