Description of event according to initial reporter: the patient presented at medical center for an unknown reason and was sent to another medical center to have the filter removed.The patient contacted the implanting physician, to report that the filter had migrated down slightly, and one foot had flipped upward.Upon removal of the filter, there was bleeding and a covered endograft was placed to control bleeding in the ivc.Patient outcome: patient was overall good.
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Manufacturers ref#: (b)(4).Summary of investigational findings: it was reported that the filter had migrated slightly down, and one leg was flipped upward.Upon removal of the filter, there was bleeding and a covered endograft was placed to control bleeding in the ivc.Patient outcome was overall good.Cook was unable to conduct a review of the device history record, as the lot number of the complaint device was not provided for the investigation.There are adequate controls in place to ensure that this type of device is manufactured to specifications.No device or images were provided for the investigation and without any images it would be inappropriate to speculate what may or may not have caused the filter to migrate.However, filter migration is a known potential adverse event.Filter or filter fragment migration and (or) embolization (e.G., movement to the heart or lungs) has been reported.Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; and (or) excessive force or manipulations near an in situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: filter migration, trauma to adjacent structures.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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