A2.The reported patient age (71 years) is representative of the mean age of all patients included in the study.A3.The reported patient sex (female) is representative of the majority of patients included in the study.Separate reports will be submitted for react catheter and serious adverse patient events.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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Dossani, r.H., waqas, m., baig, a.A., cappuzzo, j.M., popoola, d., rai, h., monteiro, a., levy, a., hashmi, e., davies, j.M., levy, e.I., & siddiqui, a.H.(2021).Walrus balloon guide catheter for stroke intervention: technical considerations and clinical outcomes.World neurosurgery, 152, e144¿e148.Https://doi.Org/10.1016/j.Wneu.2021.05.051.Medtronic review of the literature article found review of 57 patients who underwent mechanical thrombectomy procedures to treat ischemic stroke.React-71 aspiration catheters were used in 22 cases and react-68 aspiration catheters were used in 16 cases.Solitaire stent retrievers were used in 30 cases.However, it was not specified in which cases any other medtronic devices were used.There were no device malfunctions reported in the article.The article reviewed first-pass effectiveness (fpe), defined as modified thrombolysis in cerebral infarction (mtici) score of 2c and 3; an average of 1.57 passes +/- 1.16 passes were made.36 patients had a final mtici of 2c or 3.19 patients had a final mtici of 2b, and 2 patients had a final mtici of 0-2a.It was noted that one patient died during index hospitalization.The cause of death was not reported.
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