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Device Problems
Leak/Splash (1354); Occlusion Within Device (1423); Inaccurate Delivery (2339); Folded (2630)
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Patient Problems
Stroke/CVA (1770); Death (1802); Fever (1858); Unspecified Infection (1930); Ischemia (1942); Paralysis (1997); Rupture (2208); Claudication (2550); Vascular Dissection (3160)
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Event Date 10/16/2012 |
Event Type
Death
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Event Description
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The following information was obtained from a journal article.Long-term experience with endovascular therapy of the descending thoracic aorta.Jan raupach, jan vojacek, miroslav lojik, jan harrer, vendelin chovanec, alexander ferko, petr hoffmann, pavel ry¿ka, ondrej renc, antonin krajina.The following adverse events were observed: infection, stroke, death, dissection, infolding, endoleak, ischemia, conversion, occlusion, claudication, fever, paralysis.No further information is available for this event.Background: to review single centre experience of endovascular treatment of descending thoracic aorta.Methods: between (b)(6) 1999 and (b)(6) 2012, 72 patients were treated overall (53 men, 19 women, mean age 60.1 years) for degenerative aneurysms (n = 5), ruptured aneurysms (n = 4), aortic ulcers (n = 8), infected aneurysms (n = 4), type b aortic dissections (n = 23), and traumatic aortic injuries (n = 28).Results: the technical success rate was 98.6%, 30-day mortality was 8.3%, 1-year mortality was 13.8%, and overall mortality was 22.2%.Mortality caused by the treatment of aortic diseases was 6.9%.Permanent stroke occurred in 1 patient, and paraplegia developed in 1 patient.In a group of 23 patients whose left subclavian artery (lsa) was covered, claudication of the left upper extremity developed in 2 cases.Conclusions: endovascular therapy offers a very effective and less invasive alternative to the surgical approach for a wide range of the thoracic aortic disease.The main advantage of using tevar seems to be in acute conditions when a stent graft stabilizes the aorta and prevents further bleeding and organ ischemia.Regular follow-up is mandatory for early recognition of specific tevar complications.
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Manufacturer Narrative
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Date of death is unknown.(b)(4).Evaluation results: inherent risk of procedure (infection, stroke, death, dissection, infolding, endoleak, ischemia, conversion, occlusion, claudication, fever, paralysis, inaccurate delivery).(unknown cause of event).Unapproved use of device (infected aneurysm).Evaluation conclusion: (unknown cause of event).Known inherent risk of a procedure.Inherent risk of procedure (infection, stroke, death, dissection, infolding, endoleak, ischemia, conversion, occlusion, claudication, fever, paralysis, inaccurate delivery).Off ¿label, unapproved or contraindicated use (infected aneurysm).
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Search Alerts/Recalls
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