(b)(4).Catalog#: unknown but referred to as a günther tulip vena cava filter.Since catalog# is unknown the 510(k) could be either k061815, k073374 or k090140.Summary of investigational findings: imaging found that four primary legs had perforated ivc, and confirmed that one on them perforated adjacent organs, duodenum.Filter perforation of the vena cava wall is a known risk reported in the published scientific literature.Also, published scientific literature describes that manipulation in the area of filter placement could contribute to changes to the filter configuration and placement thereby potentially initiate perforation of the vena cava wall.Rpn and lot number were not provided, why device history record cannot be investigated.However, there is no evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook medical will continue to monitor for similar events.
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