Description of event according to initial reporter: celect ivc filter found to be multiply fractured with one arm in right pulmonary artery (removed), half of one leg embedded in spine (not removed as was extravascular), and half of one leg retained in filter itself but otherwise loose ie not in wall.Tip embedded.Removed filter and fragment in filter with forceps.Patient outcome: the patient required intervention to prevent permanent impairment/damage.The patient is doing well.
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Manufacturers ref# (b)(4).Summary of investigational findings: a celect filter had fractured more than 15 years after placement.Fragments removed, except from a leg extravascular and embedded in spine.Patient is doing well.The filter was not returned and no imaging could be obtained.Therefore, based on the information provided only it would be inappropriate to speculate at what may or may not have caused the filter to fracture during an implant time of more than 15 years.Filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment; 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: trauma to adjacent structures, vascular trauma.There are adequate controls in place to ensure the type of device was manufactured to specifications.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.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr 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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