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Patient allegedly received an implant on (b)(6) 2005 via the left femoral vein due to pulmonary embolism (pe), followed by a successful complex removal on (b)(6) 2020 due to fracture and migration.Patient is alleging migration, vena cava perforation, fracture, and unable to completely retrieve.Patient further alleges stress, anxiety, lower back pain, and neuropathy in feet.Report from ct: "inferior vena cava filter is noted with the inferior portion of the filter located at the l2-3 level, and the superior portion at the mid body of li." report from xray: "ap view of the abdomen shows vena cava filter satisfactorily placed at the l2 level in the region of the inferior vena cava." report from xray: "there is a inferior vena cava filter in place.New from prior ct exam ls a thin metal wire just medial to the distal aspect of the ivc filter projecting over the third vertebral body seen on both the frontal and lateral." "metal wire seen just anterior to the l3 vertebral body.Raises a concern for a fractured/migrated ivc filter leg.Recommend further investigation with noncontrast ct." report from ct: "inferior vena cava filter is noted.Just below the level of the filter there is a linear metallic foreign body coursing posterior to the abdominal aorta at the lower l3 level.This is consistent with a single leg of the filter having migrated external to the vena cava now within retroperitoneal soft tissue posterior to the aorta.Other leg of the filter protrudes slightly beyond the walls of the ivc but this appearance is unchanged.The extraluminal migrated single leg is a new finding compared to abdominal pelvic ct from 03/05/2020." retrieval report (successful): "the gunther tulip filter (main body) was then dissected free of the wall of the inferior vena cava using a 20-french sheath and the endobronchial forceps.It was removed successfully." "this procedure took more than twice the usual time, an unusually large amount of materials, and required a very high level of technical expertise and skill." "2.Cavography showed a fractured gunther tulip inferior vena cava filter.There was a fractured extravascular leg which was not in continuity with the main body of the inferior vena cava filter.The inferior vena cava appeared normal.There was no thrombus in the filter.3.After removal, the cavogram showed no transection, intussusception, venous irregularity, or thrombosis.4.Filter was inspected and found to be removed in its entirety with the exception of the extravascular leg which could not be removed." report from ct: "this dictation refers only to the ivc filter.Cook gunther tulip filter.Caval perforation: yes.Fractured strut fragment 4 o'clock, 33.8mm grade 3 extending to the posterior periphery of the abdominal aorta.Cava has been otherwise removed.Tilt: no.Migration: no.Pertinent negatives: none.Additional findings: fractured strut fragment seen posterior to the abdominal aorta as described.Curvilinear radiopaque material seen along the posterior edge of the inferior vena cava which may represent chronic thrombus." report from ct: 2: "previously seen ivc filter has been removed, with remaining remnant of fractured leg posterior to the distal abdominal aorta, not significantly changed.Oh otherwise unremarkable.Several coils are seen in the left gonadal vein.Inferior epigastric vein varices are noted.".
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: investigation.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: fracture (retained strut), vena cava perforation, thrombus, complex removal, migration, tilt, pain, stress, anxiety, neuropath.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: 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 or filter fragment migration and (or) embolization (e.G., movement to the heart or lungs) has been reported.Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; 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: filter migration, trauma to adjacent structures.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.Unknown if the reported pain, stress, anxiety, neuropathy is directly related to the filter and unable to identify a corresponding failure mode at this point in time.The catalog # and lot # are unknown, but the filter 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 becomes 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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