| Catalog Number IGTCFS-65-FEM |
| Device Problems
Difficult to Remove (1528); Unintended Movement (3026); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Edema (1820); Internal Organ Perforation (1987); Thrombus (2101); Perforation of Vessels (2135); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
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Event Description
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It is alleged that the plaintiff received a gunther filter on (b)(6) 2008.It is alleged that the plaintiff 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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Additional information: investigation: 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 ¿gunther tulip filter implanted".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.No relevant notes on work order.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.H3 other text : blank fields on this form indicate the information is unknown or unavailable, or unchanged.
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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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Investigation: 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 ¿tilt,vc perforation, unable to retrieve, thrombus/clogged filter causing lymphedema in legs".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.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 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.Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature.Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging or venography; this may be symptomatic or asymptomatic.No relevant notes on neither device or lot number.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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This additional information received on 25apr2018 as follows: pt allegedly received an implant on (b)(6) 2008 due to blood clots.Pt alleges tilt, vena cava perforation, device unable to be retrieved.Pt further alleges clots, clogged filter causing lymphedema in the legs in (b)(6) 2012.Attempted filter retrieval in (b)(6) 2008.
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Manufacturer Narrative
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F10: patient code: vessels, perforation of (2135)-listed in ifu, thrombus (2101), listed in ifu, device code: difficult to remove (1528)-not listed in ifu, no code available (3191)-device perforation-listed in ifu, unintended movement (3026) [tilt]- not listed in ifu.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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Manufacturer Narrative
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Investigation: investigation is reopened due to additional information provided.The additional information regarding organ perforation and embedment does not change the previous investigation results for vena cava perforation.The following allegations have been investigated: organ perforation, embedment, and physical limitations.Unknown if the reported physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 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 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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Additional information has been provided.Patient allegedly received an implant due to stroke and history of extensive dvt.Patient is further alleging organ perforation and "the hook is severely embedded within the ivc wall" and "the ivc filter has caused lymphedema in both legs making it to where i have to wear compression socks, all-day everyday.It's hard to go up and down steps without becoming fatigued," as well as exercise "with limitations, legs are heavy from lymphedema." report from ct (computed tomography): "the hook of the cook gunther tulip retrievable ivc filter is at the l2-3 interspace.The ivc filter is tilted anteriorly and the hook is severely embedded within the ivc wall and contacts the bowel.All the struts of the ivc filter perforate the ivc up to 19mm.One (1) anterior strut perforates the ivc wall 16mm and resides within the soft tissues.One (1) medial strut perforates the ivc wall 19mm and resides within the soft tissues.One (1) posterior strut perforates the ivc wall 17mm and contacts the l3-4 disc.One (1) lateral strut perforates the ivc wall 15mm and resides within the soft tissues.No hemorrhage seen.No thrombus is seen within the ivc.No fracture fragments are identified." "this study is compared to ct dated (b)(6) 2018.The hook of the cook gunther tulip retrievable ivc filter is at the l2-3 interspace.The ivc filter is tilted anteriorly and the hook is severely embedded within the ivc wall and contacts the bowel.All the struts of the ivc filter perforate the ivc up to 14mm.One (1) anterior strut perforates the ivc wall 8mm and resides within the soft tissues.One (1) medial strut perforates the ivc wall 14mm and resides within the soft tissues.One (1) posterior strut perforates the ivc wall 10mm and resides within the soft tissues.One (1) lateral strut perforates the ivc wall 7mm and resides within the soft tissues.Thrombus within the ivc or filter cannot be evaluated on this non contrast study.No fracture fragments are identified.".
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Search Alerts/Recalls
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