Manufacturer ref# (b)(4).Summary of investigational findings: prior to retrieval 6-7 months after placement the celect-pt filter was found to be fractured with fractured arm loosely trapped in filter.Filter and fragment were removed with forceps.No device was returned for analysis, and without the actual complaint device it would be inappropriate to speculate at what may or may not have caused the filter leg to fracture.However, it is noted that the filter had a ¿saluting arm¿ configuration soon after placement and this arm may be the fractured leg, but this is pure speculation since no imaging could be obtained.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.There are adequate controls in place to ensure that this type of device is 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 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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