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Catalog Number UNKNOWN |
Device Problems
Entrapment of Device (1212); Migration or Expulsion of Device (1395); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)
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Patient Problems
Abdominal Pain (1685); Pain (1994); Perforation (2001); Sepsis (2067); Perforation of Vessels (2135); Deformity/ Disfigurement (2360); Bowel Perforation (2668)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Age at time of event, date of birth) unknown as information was not provided.Weight) unknown as information was not provided.Date of event) unknown as information was not provided.Brand name) unknown as information was not provided.Lot#: unknown as information was not provided.Catalog#: unknown but referred to as a cook celect filter.Expiration date: unknown as lot# is unknown.Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.Device manufacture date) unknown as lot# is unknown.Summary of investigational findings: since no device or imaging studies have been available and no medical records have been made available the exact root cause for what caused the alleged tilt and perforation are unknown.It is not clear when the adverse event occurred, e.G.During or immediately after implant procedure or years after.No retrieval attempt is reported, but "multiple corrective surgical procedures", why presuming the filter is still in patient.Based on very limited information it is not possible to comment on the alleged tilt and perforation, or to comment on the severe abdominal pain, cardiac complications, multiple corrective surgical procedures, severe sepsis, acute kidney injury, and significant disfigurement allegedly experienced by patient.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during filter placement or during filter implanting period.Filter perforation of the vena cava wall is also a known risk reported in the published scientific literature.Also, published scientific literature describes that manipulation in the area of filter placement could contribute to changes to the filter configuration and placement thereby potentially initiate perforation of the vena cava wall.Rpn and lot number were not provided, why device history record cannot be investigated.It is assumed that the implant was completed and that the filter is still effective in patient.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 medical will continue to monitor for similar events.
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Event Description
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Description according to complainant: it is alleged that "[pt] received a cook celect filter on (b)(6) 2012 at the (b)(6)." according to the complaint filed, [pt]'s filter became embedded in the vena cava wall after it became tilted."additionally, all of the struts perforated through her vena cava wall, with five struts perforating into her bowel and one strut within two millimeters of perforating her aorta." patient outcome: "this malfunction resulted in severe abdominal pain, cardiac complications, multiple corrective surgical procedures, severe sepsis, acute kidney injury, and significant disfigurement.She was hospitalized for 16 days.".
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Manufacturer Narrative
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Exemption number e2016032.(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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This additional information received on 01feb2018 as follows: pt allegedly received an implant on (b)(6) 2012 via the right internal jugular vein due to pulmonary embolism (pe).Pt is alleging vena cava perforation, organ perforation (duodenal wall), migration and tilt.Pt further alleges pain, disfigurement and pain.Attempted retrieval (b)(6) 2015; ivc explanted on (b)(6) 2015 open surgery.
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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).Blank fields on this form indicate the information is unknown or unavailable, or unchanged.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, vc + organ perf., migration, tilt, diff.To retrieve (emb'd, open), kidney injury, sepsis, pain '.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.A filter that is embedded in the wall of the ivc may be difficult to retrieve.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.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.Unknown if the reported kidney injury, sepsis, is directly related to the filter and unable to identify corresponding failure mode(s) at this time.Rpn and lot# are unknown, but the celect filter 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.Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Blank fields on this form indicate the information is unknown or unavailable, or unchanged.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, vc + organ perf., migration, tilt, diff.To retrieve (emb'd, open), kidney injury, sepsis, pain '.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.A filter that is embedded in the wall of the ivc may be difficult to retrieve.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.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.Unknown if the reported kidney injury, sepsis, is directly related to the filter and unable to identify corresponding failure mode(s) at this time.Rpn and lot# are unknown, but the celect filter 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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Manufacturer Narrative
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Investigation: investigation is reopened due to additional information provided.Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Therefore, no new investigation activities will be conducted 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.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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Event Description
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02jan2015, per a report from computed tomography; ¿inferior vena cava filter with its tip likely located outside the posterior margin the inferior vena cava.There is also extension of the struts outside lumen of the inferior vena cava filter with several struts seen extending into the adjacent fourth portion of duodenum.There is marked stranding and increased density surrounding the inferior vena cava within the periaortic region.No definite active extravasation of contrast.¿.
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Search Alerts/Recalls
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