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Catalog Number UNKNOWN |
Device Problems
Structural Problem (2506); Device Tipped Over (2589); Detachment of Device or Device Component (2907); Unintended Movement (3026)
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Patient Problems
Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturers ref# (b)(4).Catalog# is unknown but referred to as cook ivc filter.Non health care professional.Summary of investigational findings: the reported allegations have been further investigated based on the information provided to date.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 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, vena cava perforation, vena cava penetration.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.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.Cook medical will continue to monitor for similar events.
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Event Description
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Description of event according to initial reporter: it is alleged that "[pt] received an unknown cook ivc filter on (b)(6) 2015.On or about (b)(6) 2019, [pt] presented to the emergency room at the hospital with chest pain.While in the hospital for chest pain, diagnostic testing performed on or about (b)(6) 2019, revealed that [pt]¿s cook ivc filter had migrated, fractured and perforated her right ventricle.On or about (b)(6) 2019, [pt] underwent surgical procedures at the hospital to remove both the cook ivc filter as well as strut that had broken off from the filter." patient outcome: it is alleged that "[pt] was injured by her cook ivc filter fracturing and migrating as a direct and proximate result of the device¿s unreasonably dangerous and defective design, and defendants¿ negligence in designing, marketing, labeling, and selling the product.[pt] was caused to suffer severe and personal injuries, which are permanent and lasting in nature, including, but not limited to, physical pain, mental anguish, diminished enjoyment of life, expenses for medical treatment, as well other personal and pecuniary harm.".
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 additional information regarding organ perforation does not change the previous investigation results for vena cava perforation.Unknown if the reported bleeding, pain, suffering, use of walker, trouble walking, physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog number and lot number are unknown.The product is manufactured and inspected according to specifications.The following allegations have been investigated: organ perforation, bleeding, pain, suffering, use of walker, trouble walking, 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 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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Patient allegedly received an implant due to deep vein thrombosis.Patient is alleging migration, fracture, bleeding, organ perforation.Patient further alleges pain, suffering, use of walker, trouble walking, issue with daily chores, physical limitations.Report from arteriography: "of note there appeared to be a small wire in the mid right ventricular region corresponding to the defect seen on ct chest (see below).It is assumed that this represents fractured ivc filter wire." report from ct: "thin metallic structure extending anteriorly through the myocardium likely in the right ventricle or less distal right atrium.Consistent with a metallic foreign body.Pericardial effusion." retrieval report (successful) 2: ".Retrieval of the ivc filter from the right internal jugular vein.Fluoroscopy identified complete removal of all metallic material and post removal inferior vena cava gram showed no extravasation.The company representative informed us there are 12 struts on the filter and we counted 11 in the removed filter, fluoroscopy showed only one metallic struck in the right ventricle." ".2to 3 millimeters of strut extruding through the epicardial fat at the acute ventricular margin and grasped the strut and removed it from the ventricle without difficulty.There was no active bleeding" retrieval report (successful): " a 6 french sheath was inserted in the right ij vein using the seldinger technique micropuncture access and ultrasound guidance.We exchanged for the retrieval sheath and advanced the lasso around the hook an snared the filter.The snare broke while retrieving the filter.We attempted to use a balloon to pin the filter in the guide but it would not release from the ivc wall.We used a bronchoscopy snare with was unsuccessful.We advanced an amplatz wire and exchanged the system for a 16f dryseal sheath.Through this we advanced a new snare system which successfully retrieved the filter.".
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Manufacturer Narrative
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Product type changed from tulip to celect.Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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.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 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, vena cava perforation, vena cava penetration.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.Unknown if the reported bleeding, pain, suffering, use of walker, trouble walking, physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog number and lot number are unknown; however, there is 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 the following allegations have been investigated: fracture, vena cava/organ/right ventricle perforation, migration, pain, bleeding, suffering, use of walker, trouble walking, 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 (b)(6) 2020/ab: the following allegations have been investigated: organ perforation, bleeding, pain, suffering, use of walker, trouble walking, 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.The following fields were updated per additional information received: h6.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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No additional information.
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Event Description
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Per a report from computed tomography (ct): "tilting with the apex against the ivc wall.6 mm vertebral and 7 mm mesenteric perforation.The filter is located across the origin of the renal veins, which may represent migration.No fracture or stenosis".
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Manufacturer Narrative
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Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: tilt.The reported allegations have been further investigated based on the information provided to date.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.Catalog number and lot number are unknown, however, the alleged celect 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 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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Search Alerts/Recalls
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