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WILLIAM COOK EUROPE COOK CELECT JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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| Catalog Number IGTCFS-65-JUG-CELECT-PERM |
| Device Problems
Difficult to Remove (1528); Obstruction of Flow (2423); Structural Problem (2506); Detachment of Device or Device Component (2907); Unintended Movement (3026)
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| Patient Problems
Pulmonary Embolism (1498); Occlusion (1984); Internal Organ Perforation (1987); Thrombosis (2100); Stenosis (2263)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturer ref# (b)(4).Summary of investigational findings: 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.Unknown if the reported lifelong anticoagulants, back/abdominal/lower extremity pain, abdominal discomfort, lower extremity swelling, fatigue, stress, anxiety, insomnia, fear, and limited physical activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.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.Cook medical will continue to monitor for similar events.
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Event Description
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Description of event according to short form complaint filed:: it is alleged that "[pt] received a cook celect filter on (b)(6) 2009." additional information provided 29apr2020: patient allegedly received an implant via right jugular vein due to protein c deficiency, history of deep vein thrombosis (dvt) and pulmonary embolism (pe), scheduled for sigmoid resection for diverticulitis.Patient is alleging migration, vena cava perforation, fracture, organ perforation, thrombus at the filter level, lifelong anticoagulants, perforation of spine, aorta, small intestine, ureter, intermittent stabbing lower back pain, unknown abdominal pain, dvt in lower extremity.The patient further alleges stabbing pain with twisting movements, abdominal discomfort, lower extremity swelling/pain, fatigue, lower left quadrant pain, stress, anxiety and insomnia.Patient further alleges she will have to undergo procedure to try and remove the fractured filter.On (b)(6) 2009, ivc filter implant operative report: ¿the celect filter was deployed in the infrarenal inferior vena cava below the level of the left renal vein.Impression: successful placement of an infrarenal retrievable celect ivc filter.¿ on (b)(6) 2015, ct of abdomen and pelvis: ¿ivc filter is present¿.Per a computerized tomography (ct) scan of the abdomen and pelvis dated (b)(6) 2015, ¿ivc filter in place again.Today associated with the filter as well as inferior to this in the dep veins of the pelvis there does appear to be increased intraluminal thrombus now.With this noted some of the thrombus material appears to be propagating to the most superior extent of the filter.¿ per a venogram dated (b)(6) 2015, ¿findings: occlusion of the right common iliac vein with thrombus extending into the right internal iliac vein.The inferior vena cava is thrombosed from the ivc filter to the common iliac vein.Thrombotic occlusion of the left external iliac and common iliac veins.Impression: acute/subacute thrombus involving the right common iliac vein, left external iliac vein, left common iliac vein, distal inferior vena cava to the level of the ivc filteracute/subacute thrombus involving the right common iliac vein, left external iliac vein, left common iliac vein, distal inferior vena cava to the level of the ivc filter.¿ on (b)(6) 2015, venogram with thrombectomy results: ¿impression: follow up venogram demonstrated some residual thrombus in the iliac veins extending up to the filter.It appears improved when compared to the previous study.Manual catheter directed suction thrombectomy was performed on both right and left iliac veins and within the filter.Large amounts of thrombus was removed.¿per ct of abdomen dated (b)(6) 2019, ¿impression: ivc filter with fractured posterior limb extending into the anterior l4-l5 disc and l5 vertebral body.¿ patient outcome: unknown.
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Event Description
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It is alleged the patient underwent a successful, complex filter retrieval on (b)(6) 2020.Report from computerized tomography (ct): "ivc filter in place." "infrarenal ivc filter remains in place with some of the legs projecting beyond the vascular lumen, as is not unusual." per the retrieval report (successful): "acute thrombotic occlusion of the inferior vena cava, bilateral iliac veins, bilateral femoral veins, and bilateral tibial veins with marked bilateral lower extremity edema from the hips to the toes bilateral lower extremity pain prohibiting ambulation.History of acute subacute thrombus in the filter containing inferior vena cava, right common iliac vein, left common iliac vein, and left external iliac vein treated with ultrasound mediated catheter directed tpa thrombolysis 2015." "portions of 2 fractured legs remained behind l4 vertebral body, precaval retroperitoneal fat).Diagnostic venography demonstrates extensive thrombus from the ivc filter through the bilateral popliteal veins." " proximal left common iliac vein persistent stenosis requiring placement of kissing bilateral iliac stents to maintain patency." "infrarenal ivc near the iliac confluence.Fractured leg is known to be within the l5 vertebral body, one fracture leg is precaval retroperitoneal fat as identified on ct scan." " unable to capture the filter hook with the standard retrieval set.Therefore advanced techniques were required." "the laser was activated and the sheath was advanced slowly, collapsing the filter legs and retracting the filter into the sheath.The filter was inspected on the back table--all 8 stabilizing wires were present; 2 intact legs were present; 2 short, fractured legs were present"."additional procedure: mechanical or aspiration thrombectomy.Tiny amounts of thrombus remain adherent to the valves.".
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Manufacturer Narrative
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Additional information: investigation.The following allegations have been investigated: occlusion, stenosis, complex removal.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 occlusion and stenosis does not change the previous investigation results for filter thrombus and deep vein thrombosis (dvt).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.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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