Exemption number e2016032.(b)(4).Summary of investigational findings: investigation is based on event description only.No product is returned and no imaging is available.Therefore, it would be inappropriate to speculate at what may or may not have caused the filter no not spring open based on the limited information made available to us.However, it is previously seen that the filter legs may be somehow obstructed from fully expanding due to e.G.Ivc anatomical conditions, clots or if the filter is not placed in ivc.It is noted that "it was removed from the patient without any complications".During the manufacturing/qc processes the spring effect of every filter is 100% controlled, as they are all deployed after advancement through a testing sheath.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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