Medtronic received the following information from a journal article entitled: comparison of chimney and fenestrated techniques for supraaortic branch revascularization during thoracic endovascular aortic repair: a systematic review and meta-analysis mingyu liu , xinyi wu , song wu, xinyang li , shijie xin, jian zhang cardiovascular interventional radiology (2023) 46:1315¿1328 https://doi.Org/10.1007/s00270-023-03537-4 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Talent and valiant stent grafts were implanted in thoracic endovascular aortic repairs on unknown dates over a 22 year period. 153 studies were included in this systematic review. the patients in the studies underwent either fenestrated thoracic endovascular aortic repair (ftevar) or chimney thoracic endovascular aortic repair ( ch-evar) of aortic disease.The following malfunctions were reported: type ia endoleak, migration, deformation in vivo the following adverse events were reported; stroke, occlusion patient mortality was reported but there is no causal link that a mdt stent graft caused or contributed to any death.
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