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Patient allegedly received an implant on (b)(6) 2015 via the left femoral vein due to deep vein thrombosis (dvt).This filter was found to be located at the left side of l5-s1 overlying the left common iliac vein.Allegedly, a second cook filter was later implanted on an unknown date in the patient's inferior vena cava and found to be at the level of the l3 vertebral body.An unsuccessful retrieval attempt of both filters was performed on (b)(6) 2015.This report concerns the celect filter which allegedly overlies the left common iliac vessel and which, per the medical record, is embedded with the tines extending extravascularly.The patient further alleges "shortness of breath and breathing problems, unable to walk any distances unless short, unable to run at all, chest pains, stomach trouble and problems, movement and activity is severely limited" as well as depression and anxiety.Retrieval report (attempted): "multiple attempts were made to retrieve the inferior vena cava.These were unsuccessful and on oblique imaging it was found that the hook of the caval filter was embedded into the wall of the vena cava.The wire was guided down to the left iliac vein and the sheath advanced over this and the left iliac venogram was obtained.Again, it showed that the hook was embedded into the wall and there was no retrieval attempted." report from ct: "there is a filter within the left common iliac vein with tines extending extravascularly.There is an infrarenal ivc filter with tines also extending-extravascularly and one of the tines appearing to enter the abdominal aorta and another time penetrating through the cortex of the right anterior inferior corner of the l3 vertebral body.".
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This file addresses the patient's iliac filter.The patient's caval filter is addressed in mfr# 3002808486-2021-01271.Investigation: the following allegations have been investigated: iliac vein perforation/embedment, unable to remove, dyspnea, physical limitations, chest pain, stomach problems, anxiety, depression.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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.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.Unknown if the reported dyspnea, physical limitations, chest pain, stomach problems, anxiety, depression 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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