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Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: embedment, deep vein thrombus/ thrombosis, stenosis, failed removal/inability to retrieve, tilt, stress, physical therapy, emergency removal, anxiety.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, vena cava perforation, vena cava penetration.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.Physician practice guidelines and published guidance from regulatory agencies recommend that patients with indwelling filters undergo routine follow-up.The risks/benefits of filter retrieval should be considered for each patient during follow-up.Once protection from pe is no longer necessary, filter retrieval should be considered.Filter retrieval should be attempted when feasible and clinically indicated.Filter retrieval is a patient-specific, clinically complex decision; the decision to remove a filter should be based on each patient¿s individual risk/benefit profile (e.G., a patient¿s continued need for protection from pe compared to their experience with and (or) ongoing risk of experiencing filter-related complications).For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.The filter is designed to be retrieved with the günther tulip vena cava filter retrieval set.It may also be retrieved with the cloversnare® vascular retriever.Cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques.The published clinical literature includes descriptions of alternative techniques for filter retrieval; use of these techniques varies according to physician experience, patient anatomy, and filter position.The safety or effectiveness of these alternative retrieval techniques has not been established.Specific for ¿embedded¿ a filter that is embedded in the wall of the ivc may be difficult to retrieve.For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.Unknown if the reported stress, physical therapy, emergency removal, anxiety are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.No relevant notes on work order.The product is manufactured and inspected according to specifications.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information become available.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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Patient allegedly received an implant via the right internal jugular vein due to deep vein thrombosis.Patient is alleging tilt, deep vein thrombosis, embedment, failed removal/inability to retrieve.Patient further alleges stress, thrombosis, physical therapy, emergency removal, anxiety and blood clots.Report from computerized tomography (ct): "ivc filter is seen in place." "mild circumferential mural thrombus involving the distal abdominal aorta." "ivc filter appears appropriately positioned and although the inferior vena cava is poorly opacified there is no evidence to suggest clot." retrieval report: "a simple snare was then used to try to get the apex of the filter, which was unsuccessful." "a reverse catheter was used and a glidewire was passed posterior to the filter apex.A snare was used to grasp the proximal end of the wire and the glidewire wire was externalized.Using both ends of the wire gentle traction was applied to the apex of the filter.An ensnare was used but the apex of the filter still could not be grasped.I then used gentle dissection with the endobronchial forceps but could not free the apex of the catheter.I then used 10 and 12 mm balloons posterior to the filter in an attempt to displace the filter anteriorly.Despite these maneuvers, i could not free up the apex of the filter so that it could be successfully snared.After 2 hours and multiple retrieval attempts using all available techniques, i abandoned the filter retrieval." report from thrombectomy: "there is extensive thrombus present within the popliteal vein, femoral vein, common femoral vein, external iliac vein, common iliac vein and ivc filter.The ivc beyond the ivc filter is widely patent.The left common iliac vein has a moderate stenosis, there is no thrombus present within the left external iliac vein.Next, i crossed the extensive thrombus and advanced catheter through the ivc filter into the patent ivc.Next, the angiojet device was brought to the operative field and prepped.Next, the extensive thrombus from the popliteal vein to the level of the ivc filter was treated with mechanical thrombectomy using the angiojet device.A completion angiogram showed some resolution of thrombus however, there was a significant residual thrombus.Hence, a 50 cm ekos thrombolytic catheter was placed from just inferior to the ivc filter to the popliteal vein and secured in place with the venous sheath.".
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