(b)(4).Lot#: unknown as information was not provided.Catalog#: igtcfs-65-uni-celect expiration date: unknown as lot# is unknown.Similar to device under 510(k) k073374.(b)(4).Summary of investigational findings: available images from deployment confirm that the filter placement looked normal.But the images also confirm that the filter had tilted 14 days after placement.However, filter configuration is normal.It was not possible to cover the filter completely with the inner and outer sheath of the gtrs-200-rb, since the filter legs were attached to the vena cava wall.Imaging from retrieval attempt show that the filter collapsed partly.Most likely the physician twisted the gtrs-200-rb during the retrieval attempt and thereby the filter legs got entangled and stayed collapsed when gtrs-200-rb was removed.Tilt is considered as a well known risk, which is described in the scientific literature.Cook medical will continue to monitor for similar events.
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