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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Reocclusion (1985)
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Event Date 08/28/2019 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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This article aims to evaluate the frequency of primary obstruction events (pro) during one-year follow-up after performing excisional atherectomy with the silverhawk/turbohawk atherectomy device s/th or remote superficial femoral artery endarterectomy (rsfae) in patients with the chronic superficial femoral artery occlusive disease (sfaod).All randomized clinical trials (rcts) and not-rcts concerning the treatment of patients with sfaod after s/th and rsfae without duration.27 articles on the levels of evidence were included in qualitative synthesis; 9 studies (meta-analysis) were included in quantitative synthesis.The results of 2762 patients¿ treatment were evaluated.Primary obstruction events (pro) reported were restenosis and occlusion during one-year follow-up with target lesion revascularization carried out to treat the restenosis and occlusion.The article reports 792 out of 2762 people experienced pro.The study concluded that s/th with the spiderfx device (distal embolic protection) are safe and effective treatment option for short lesion (15 cm) in patients with sfaod, rsfae may be considered better than an endovascular procedure.
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Search Alerts/Recalls
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