(b)(4) igtcfs-65-1-jug-celect-pt.Summary of investigational findings: the returned filter had two intertwined filter legs.Furthermore, a third filter leg was deformed and there was deformities on the introducer.Since no imaging is provided, it is unknown if the filter legs were crossed during placement.However, since the returned filter had two crossed legs and a third deformed leg and since the introducer was damaged, probably the filter was twisted while advancing it through the sheath resulting in the secondary filter legs to become intertwined.During the manufacturing/qc processes the spring effect of filter is 100 % controlled, as they are all deployed after advancement through a sheath.Under normal conditions, ivc< 30 mm, the radial force of filter will make filter legs attach to ivc.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
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