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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
Fracture (1260); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Insufficient Information (3190)
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| Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Pain (1994); Perforation of Vessels (2135); Stenosis (2263); Anxiety (2328); Blood Loss (2597); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Catalog# is unknown but referred to as cook celect filter.Name and address for importer site: (b)(4).It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date. cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.
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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) 2012".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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Wce follow-up medwatch report exemption number: e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Mfr site: name and address for importer site: (b)(4).Additional information: investigation: 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 'celect, fracture, organ + vc perforation, migration, unable to retrieve, pain, sob, anxiety'.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 shortness of breath, pain/discomfort is directly related to the filter.Unknown if the reported anxiety is directly related to the filter and unable to identify corresponding failure mode(s) at this time.20 devices in 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 provided at this time.
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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.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: stenosis, embedded, bleeding.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 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.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 bleeding is directly related to the filter.No relevant notes found on work order or device lot.No other complaints on lot.Product is manufactured and inspected according to specifications.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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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Patient alleges stenosis, embedment, bleeding.Per ct, (b)(6) 2016: " the posterior ivc filter strut enters the l3 vertebral body anteriorly and has broken off from the remainder of the inferior vena cava filter.
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Event Description
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This additional information received on 22jun2018 as follows: pt allegedly received an implant on (b)(6) 2012 via the right femoral vein due to pulmonary emboli and deep vein thrombosis.Pt alleges migration (through walls of the ivc into the duodenum), vena cava perforation, fracture (filter leg), device unable to be retrieved.Pt further alleges abdominal pain, chest pain, shortness of breath, lower back pain with spasms, anxiety.
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Manufacturer Narrative
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Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Patient code:vessels, perforation of (2135)-listed in the ifu,pain (1994)- not listed in ifu, anxiety (2328)- not listed in ifu.Device code: -migration of device or device component (1395)-listed in the ifu, fracture (1260)- listed in ifu, difficult to remove (1528)- not listed in ifu.Name and address for importer site: (b)(4).Blank fields on this form indicate the information is unknown or unavailable, or unchanged.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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