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Model Number UNK-CV-SR-VALIANT |
Device Problems
Leak/Splash (1354); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2023 |
Event Type
malfunction
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Event Description
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Valiant and non mdt stent grafts were implanted in 22 patients for the endovascular treatment of thoracic aortic aneurysms on unknown dates over a 10 year period. during the tevar, the patients also underwent surgical revascularization of the lsa to extend proximal sealing in zone 2.The following malfunctions were reported; type ia endoleak, type ib endoleak, type iii endoleak (probably fabric tear) , deployment (birdbeak configuration) the following adverse events were reported; spinal cord ischemia, paraplegia, re-intervention patient mortality was reported but there is no causal link that a valiant stent graft caused or contributed to any death.
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Manufacturer Narrative
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Medtronic received the following information from a journal article entitled; determination of the gained proximal sealing zone length after debranching of the left subclavian artery in thoracic endovascular aortic repair dieleman im, zuidema r, de beaufort hw, gallitto e, spath p, logiacco a, et al.The journal of cardiovascular surgery 2023;64:134-41.Doi: 10.23736/s0021-9509.23.12578-x 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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Search Alerts/Recalls
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