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WILLIAM COOK EUROPE COOK CELECT FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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| Catalog Number IGTCFS-65-FEM-CELECT-PERM |
| Device Problems
Material Erosion (1214); Fracture (1260); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Structural Problem (2506); Insufficient Information (3190)
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| Patient Problems
Internal Organ Perforation (1987); Perforation of Vessels (2135); Blood Loss (2597); Device Embedded In Tissue or Plaque (3165); No Information (3190)
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| Event Date 07/15/2013 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Catalog#: unknown but referred to as a cook celect filter.Name and address for importer site: (b)(4).Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.(b)(4).Investigation is still in progress.
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Event Description
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Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2013".Patient outcome: it is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.
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Manufacturer Narrative
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(b)(4).Name and address for importer site: (b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
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Event Description
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This additional information received on 06/19/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2013 via the common femoral vein due to deep vein thrombosis.Plaintiff is alleging vena cava perforation, organ perforation, bleeding, device migration and unable to be retrieved.Plaintiff alleges severe pain, shortness of breath, elevated white blood cell count, difficulty swallowing and an aversion to certain foods.Plaintiff alleges attempted retrieval on (b)(6) 2013 and retrieval on (b)(6) 2016 however a portion of the strut was not able to removed.
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Manufacturer Narrative
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Manufacturer reference # (b)(4).Exemption number e2016032.(b)(4).It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'vena cava and organ perforation, bleeding, migration, fracture, unable to be retrieved, pain, dyspnea'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.Filter fracture is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Fracture of a filter leg can be due to repetitive motion on a filter leg in an unusual stressed position.Among other causes, filter fracture may be associated with a filter leg perforating the ivc, a filter leg being caught in a side branch (e.G.Renal vein), excessive force or manipulations near an implanted filter (e.G.A surgical procedure in the vicinity of a filter) and / or procedures that involve other devices being passed through an in situ filter.It has been reported that retrieval of a fractured filter or filter fragments using endovascular techniques is possible.Fracture of the wire is a known risk in relation to an implanted filter and reported in the published scientific literature.It is known from the published scientific literature that a filter fragment embolized into the heart or lung may be safely retrieved.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Unknown if the reported pain and dyspnea is directly related to the filter and unable to identify a corresponding failure mode at this 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.
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Manufacturer Narrative
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Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: cook medical incorporated (cmi) (b)(4).Registration no.: (b)(4).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.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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Event Description
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Per a ct scan performed on (b)(6) 2016 " the findings demonstrate tract from erosion of the ivc filter into the anterior inferior aspect of the l3 vertebral body with sclerotic margin.There is reactive marrow edema adjacent to the area of bone erosion.".
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Manufacturer Narrative
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Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: cook medical incorporated (cmi), 400 daniels way, bloomington, in 47404, registration no.: 3005580113.Investigation is reopened due to additional information provided.It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating "fracture, vc/organ perforation, bleeding, migration, unable to retrieve, pain, dyspnea, erosion." cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.Filter fracture is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Fracture of a filter leg can be due to repetitive motion on a filter leg in an unusual stressed position.Among other causes, filter fracture may be associated with a filter leg perforating the ivc, a filter leg being caught in a side branch (e.G.Renal vein), excessive force or manipulations near an implanted filter (e.G.A surgical procedure in the vicinity of a filter) and / or procedures that involve other devices being passed through an in situ filter.It has been reported that retrieval of a fractured filter or filter fragments using endovascular techniques is possible.Fracture of the wire is a known risk in relation to an implanted filter and reported in the published scientific literature.It is known from the published scientific literature that a filter fragment embolized into the heart or lung may be safely retrieved.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Unknown if the reported pain, bleeding, erosion and dyspnea are directly related to the filter and unable to identify a corresponding failure mode at this time.No relevant notes found on work order or device lot.No other complaints on lot.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.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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Event Description
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No additional information has been provided at this time.
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Event Description
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Report from ct (computed tomography) spine/lumbar: "findings: interval removal of the ivc filter.At the l3 level, posterior medial to the inferior vena cava is a curvilinear metallic foreign body measuring 9 mm long.Located 10 mm ventral to the l3 body." "curvilinear metallic foreign body posterior to the inferior vena cava, ventral to the l3 body is consistent with a fractured support arm from the removed inferior vena cava filter." ct abdomen/pelvis: "there is small filling defect in the inferior vena cava where the nose cone of the inferior vena cava was embedded in the wall with endotracheal overgrowth.No identified ivc thrombosis.Discussed above is a small area of fat stranding and soft tissue density which is diminishing in size between the liver, duodenum, and inferior vena cava where a extravascular leg was located.No identified duodenal caval fistula.No retroperitoneal gas.A portion of a previous support arm of the filter has a short fractured segment between the aorta and ivc, likely fractured from aortic pulsation.This fragment measures 0.9 cm in length and is observed best on series 602 image 31.There is mild prevertebral fat stranding adjacent to the small lytic area in l3, this area appears improving.Traversing lumbar arteries are noted without enhancing fluid collection.".
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Manufacturer Narrative
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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: embedment.The additional information regarding embedment does not change the previous investigation results for organ/vena cava perforation.(b)(4) devices in lot.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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