Manufacturer ref# (b)(4).Summary of investigational findings: it was reported that the ivc filter was retrieved but a secondary strut was left in the patient, outside of the ivc and still embedded in the bone.However, the physician "wasn't worried about it and couldn't get to it".On the limited images submitted for review, there does appear to be a gunther tulip ivc filter in the infrarenal ivc.There is no evidence of significant tilt.There are two grade 3 interactions present and two grade 2 interactions present.The primary filter leg at the 9:00 region appears to abut either the right gonadal vein or potentially the right ureter without any significant changes to suggest inflammation or hemorrhage.The primary filter leg at the 6:00 region abuts the l3 vertebral body and has incited a prolific sclerotic bony reaction creating a bridging osteophyte extending between the l3-l4 vertebral body.As seen on the venogram images from time of ivc filter retrieval, and confirmed in the complaint report, the ivc filter was retrieved.However, the complaint report states a secondary strut was left in the patient, outside of the ivc and still embedded in the bone.This is not appreciated on the post-retrieval fluoroscopic image and may be a limitation due to the lower resolution of the image provided for review.The cause of filter fracture in this case is indeterminate.However, 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).Furthermore, retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques may include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.No product was returned and device name, rpn and work order number is unknown.No evidence to suggest this device was not manufactured to specifications.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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