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| Catalog Number UNKNOWN |
| Device Problems
Difficult to Remove (1528); Inadequate Filtration Process (2308); Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589); Detachment of Device or Device Component (2907); Unintended Movement (3026)
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| Patient Problems
Pulmonary Embolism (1498); Erosion (1750); Internal Organ Perforation (1987); Scar Tissue (2060); Perforation of Vessels (2135); Stenosis (2263); Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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Occupation: non-healthcare professional.Investigation: the reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: fracture, migration.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 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.Catalog number and lot number are unknown.The alleged celectis 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.
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Event Description
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The following information is alleged: the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2015.Approximately 4 years and 9 months later the patient underwent a computed tomography scan that revealed at least two fractured legs of the ivc filter, as well as migration of the filter.Hospital and medical records have been requested, but not yet provided.
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Manufacturer Narrative
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Investigation: investigation is reopened due to additional information provided.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.The additional information regarding retained fragments does not change the previous investigation results for fracture.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.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 inferior vena cava (ivc) erosion/repair, kidney damage, scarring lungs/abdomen, multiple surgical procedures, and physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot numbers are unknown, however, the alleged celect is manufactured and inspected according to specifications.The following allegations have been investigated: pulmonary embolism (pe), retained fragments, organ/vena cava (vc) perforaton, embedded, dvt, ivc stenosis/venous occlusion, difficult to remove, tilt, ivc erosion/repair, kidney damage, scarring lungs/abdomen, multiple surgical procedures, physical limitations.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 report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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Patient allegedly received a filter via the right common femoral vein due to left lower extremity deep vein thrombosis (dvt) with pulmonary embolism (pe).Reportedly the patient underwent two unsuccessful percutaneous filter retrieval attempts, (b)(6) 2015 due to dvt/pe and (b)(6) 2019 due to filter tilt and erosion through the ivc, and a successful open surgical retrieval 16oct2019 for embedment.A final surgery was reported which occurred (b)(6) 2020 to successfully remove a fractured piece of the filter from the right kidney.Patient is alleging device migration, tilt, and fracture, organ perforation, embedment, and erosion.Patient notes and further alleges experiencing " bovine calf heart patch.Kidney was damaged by fractured ivc filter leg that was embedded.The scarring on lungs from multiple p.E's" and "a scar on abdomen from umbilical to breast bone from multiple surgeries", as well as physical limitations.Per an unsuccessful ivc filter removal: "operative findings: access obtained without issue.Ivc filter in place but tipped compared to placement xray.At placement it was upright and in excellent location.Today the retrieval hook appears embedded in the wall.Unable to remove.No complications.Venacavogram without thrombus in the filter.Tolerated procedure well"."unable to snare the filter secondary to its tipped position.Left in place".Per a computed tomography (ct) venogram abdomen and pelvis: "hx [history] of dvt that developed into a pe due to this ivc filter was placed"."lung bases: no pulmonary parenchymal mass or pleural effusion"."kidneys and ureters: there is a 35mm linear metallic fragment projecting from the renal pelvis into the parenchyma of the right kidney, consistent with a fractured and migrated leg from the patient's ivc filter.No hydronephrosis"."impression: positioning of the ivc filter is described, with at least 2 fractured legs of the ivc filter, one projecting medial to the ivc at the level of l2-3 and the second displaced then migrated into the right renal hilum and parenchyma.Given the fact that the apex of the filter has migrated extravascular this could not be retrieved percutaneously.The more lateral legs also appear to extend beyond the wall of the inferior vena cava".Per an ivc venogram/unsuccessful filter removal: "findings ivc filter that is tilted and has eroded through the inferior vena cava wall.Despite getting loop control of the filter both proximally and distally, i could not mobilize the filter enough to get it back into the ivc to be snared"."despite multiple attempts and applying traction and counter traction, i could not get the filter to reposition back into the lumen.At this point, the patient was getting significantly uncomfortable.I decided to stop and will plan an open ivc filter retrieval on a separate occasion.Both the venous sheaths were pulled and manual pressure was held for hemostasis the patient was transferred out to the pacu in stable condition".Per a ct angiography abdomen and pelvis: "there is an ivc filter present.As demonstrated on recent cavogram the filter is significantly tilted.There are legs extending laterally to the right as described on previous cavogram.There is also a fractured leg present in the parenchyma of the right kidney, and a second displaced leg extending medially to the midline at the level of the ivc filter (l3).These are unchanged.There is new thrombus in the inferior vena cava, extending into the right common iliac vein"."there is possible extension of the ivc filter legs into the loop of bowel.No inflammatory mass or abscess is demonstrated at this time".Per a ct angiography chest: "there are new focal parenchymal opacities in the right middle and lower lobe without evidence of cavitation.There located in the periphery of the lung and are associated with subtle peripheral pulmonary embolus the most conspicuous located on image 58 of series 300 in the left lung there is a 4 mm nodule, image 26 of series 4.No definite emboli on the left side, but on image 53 of series 3 there is a questionable filling defect in a lower lobe pulmonary artery".Per the open surgical removal of ivc filter report: "findings around the infra renal ivc in the region of the filter.The patient had several tines which protruded from the lumen of the ivc, but none of them were inside the duodenum.The cap of the device was imbedded into the medial wall of the ivc, but visible through it.There was thickening inside the vena cava in this area.There were multiple dilated lumbar veins likely from the chronic left iliac venous occlusion, almost all of the lumbar veins were preserved.This case was substantially more difficult than usual because of significant effort and difficulty mobilizing and identifying anatomical structures due to altered surgical field secondary to inflammation"."the ivc was opened at the gonadal vein confluence, and the venotomy extended proximally distally for 7 cm segment.Multiple tines of the filter were cut and removed.A separate venotomy was made on the medial ivc wall to expose the ap of the device.The remaining filter was removed intact".Per the retained right kidney foreign body removal: "gentle retrograde pyelography was performed demonstrating mild right hydroureteronephrosis down to the pelvic brim, hyperdense ivc filter single fragment visualized under fluoroscopy.There was no obvious area of stricture or obstruction"."the foreign body was seen in the mid pole calyx, it was metallic appearing with some initial stone encrustation seen"."findings details: retained metallic fragment removed from the kidney successfully, minimal trauma".Per a ct abdomen and pelvis: "on ct imaging, included portions of the lung bases are unremarkable"."an approximate 1.7 cm long constriction of the ivc is identified in this area.Multiple metallic fragments also reside in this region and could represent fragments from the reported ivc filter"."conclusion: 1.The infrarenal ivc does become quite diminutive with a 1.7 cm long segment that is quite stenosed.More inferiorly the ivc has a more normal caliber, though enhancement is heterogeneous and incomplete.2.Furthermore the left common iliac vein is quite diminutive and difficult to see.It may be partially thrombosed.Noticeable pelvic varicosities, accordingly.The suprarenal ivc is more normal-appearing".Per the telephone report to patient: "narrowing of the ivc with residual tiny metallic fragments just below the are of the renal vein.There is narrowing or possible thrombosis of the left common iliac vein with resulting varicose veins at the pelvis.No metallic fragments seen within organs or blood vessels.Normal pancreas.Spleen.And kidneys".
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Search Alerts/Recalls
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