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COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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| Catalog Number IGTCFS-65-FEM |
| Device Problems
Difficult to Remove (1528); Inadequate Filtration Process (2308); Obstruction of Flow (2423); Detachment of Device or Device Component (2907); Unintended Movement (3026)
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| Patient Problems
Pulmonary Embolism (1498); Dyspnea (1816); Internal Organ Perforation (1987); Perforation of Vessels (2135); Stenosis (2263); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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The previous medwatch report was submitted by william cook europe under manufacturer report reference# 3002808486-2021-01125.Additional information provided determined that this device was manufactured by cook inc.With the submission of this initial medwatch report, cook inc.Informs that all future submissions regarding this complaint will be handled under the manufacturer report reference # referenced in this report.Initial reporter occupation: non-healthcare professional.Investigation: the following allegations have been investigated: pulmonary embolism (pe), fracture, organ/aorta/vena cava (vc) perforation, thrombosis, stenosis, migration.The reported allegations have been further investigated based on the information provided to date.New pe 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: pulmonary embolism.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: 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.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.A total of 20 devices were manufactured in the reported lot.To date, one other complaint has been reported against the lot 2483465.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to current controls.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.
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Event Description
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The following information is alleged: the patient received a tulip inferior vena cava (ivc) filter on (b)(6) 2010 via the right common femoral vein due to deep vein thrombosis (dvt) and pulmonary embolism (pe) and an inability to take anticoagulants.The patient underwent a computed tomography (ct) scan approximately 6 years and 8 months later which indicated that the ivc filter had migrated since its implantation as several struts were now perforating through the ivc wall and into the abdominal aorta.Further testing the following day indicated that the ivc filter had also fractured and was located in the abdominal aorta.The patient alleges migration, vena cava and organ perforation, device fracture.Allegedly, the patient had previously received a cook gunther tulip filter implanted on (b)(6) 2010 and another manufacturer's filter implanted (b)(6) 2010 due to post deep vein thrombosis and pulmonary embolism.The patient allegations detailed above are in reference to the filter lot number documented in this report.(b)(6) 2016, per a report from computed tomography; "findings: lower chest: right lower lobe segmental pulmonary embolus".Findings suspicious for thrombosis of the inferior vena cava within and below the filter extending into the pelvic veins.(b)(6) 2016, per a report from xray; impression; complete acute thrombosis of the infrarenal inferior vena cave and pelvic veins, thrombus within the ivc filter.No thrombus above the filter.(b)(6) 2016 , per a report from venogram; penumbra suction thrombectomy was then performed from the level of sheath in the popliteal to the external iliac vein.Approximately 600 to 800ml of clot were retrieved and at no point there was free blood ever encountered.Repeat venography showed the creation of some lumen within the femoral and popliteal systems but without adequate outflow"."the decision at that point was made to proceed with continuous lytic drip and so, an infusion catheter was brought onto the field, advanced over a wire again to a point with the tip of the infusion catheter was at the tip of the ivc filter, and the infusion ports then extended from the tip of the ivc filter to the mid femoral vein"."the plan was for the patient to be transferred to the icu for 1.5 mg an hour infusion via the lytic catheter overnight".(b)(6) 2016, per a report from venogram; per a report from venogram/angioplasty/stent placement; "venography via this sheath was then performed which showed a clear flow channel from the popliteal vein to the level of the ivc filter.There appeared to be persistent thrombus and stenosis within the left iliac vein.The infusion catheter was removed and angioplasty of the left illiac system was performed with a 10 x 40 mm mustang balloon.This confirmed the presence of significant stenosis within the iliac system from iliac confluence with the ivc to the level of the external iliac common femoral junction"."1 23 mm valve stent was brought onto the field and deployed using bony landmarks of the bottom of l3 to approximately 4 cm short of the left femoral head".Completion venography was consistent with the ivus findings with no hemodynamically significant narrowing and/or clot from the common femoral vein to the level of the ivc filter.(b)(6) 2018, per a report from computed tomography; inferior vena cava: ivc filter is noted below the level of the renal veins.One of the lateral limbs of the filter extends into the adjacent abdominal aorta.2 other limbs of the filter extend outside the lumen of the ivc to the adjacent fat.(b)(6) 2018, per a report from computed tomography; ivc filter in similar position with a limb in the abdominal aorta as noted previously.
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Event Description
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The patient alleges unable to be removed.The patient alleges leg swelling, loss of breath, filter clogging, fear, and limited activities.
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Manufacturer Narrative
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Investigation the following allegations have been investigated: clogging, unable to remove, leg swelling, loss of breath, fear, and limited activities.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The additional information regarding clogging does not change the previous investigation results for thrombosis and stenosis.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 leg swelling, loss of breath, fear, and limited activities are directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) 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 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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