WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Catalog Number IGTCFS-65-1-FEM-CELECT-PT |
Device Problems
Structural Problem (2506); Device Tipped Over (2589); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problems
Skin Discoloration (2074); Perforation of Vessels (2135); Dizziness (2194); Numbness (2415); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.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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'it is alleged that "[pt] received a cook celect filter on (b)(6) 2017".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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Device code(s): appropriate term/code not available (3191) was selected for the alleged device perforation.Device code(s): appropriate term/code not available (3191) was selected for the alleged device tilt.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 on (b)(6) 2017 via the right common femoral vein due to venous thromboembolism (vt) and pulmonary embolism (pe).Patient is alleging tilt and vena cava perforation.The patient further alleges "living daily with fact that if this device ever begins to fall apart that i will most likely die.Legs turn purple all way to feet and toes when not elevated.I do have some numbness and tingling in both feet can calves at times.Occasional dizziness without any cause." "i use a wheelchair for mobility." (b)(6) 2017, implant report: "the right common femoral vein was entered percutaneously and the guidewire was passed under fluoroscopic guidance into the inferior vena cava." "the filter was then prepared for deployment and passed through the sheath and deployed at the l2-l3 level below the level of the renal veins." (b)(6) 2019, report from ct (computed tomography): "filter device is present within the infrarenal ivc.There is slight anterior and left lateral tilting of the apex of the filter.No strut fracture is present.The anchors of the filter penetrate the wall of the ivc.No penetration of adjacent vital structures is present.Patency of the lumen of the ivc cannot be determined due to lack of iv contrast.".
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Manufacturer Narrative
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Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Vena cava wall penetration/perforation has been reported and 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 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.Unknown if the reported legs turning purple, foot numbness/tingling, dizziness, and physical disability 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.No other complaints on lots.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.The following allegations have been investigated: vena cava perforation, tilt, legs turning purple, foot numbness/tingling, dizziness, and physical disability.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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No additional information has been provided at this time.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The following fields were updated per additional information received: b5, b6, and h6.Additional information: 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.20 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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Event Description
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Report from ct (computed tomography): ""filter type: cook.Ivc stenosis: no.Filter cone position: below the renal veins.Filter migration: no.Filter fracture/bending: no.Filter tilt: no.Filter penetration: yes.Other findings: no.Impressions: the anterior strut penetrates 4 mm through the ivc wall.Sagittal image 88.The left strut penetrates 5 mm through the ivc wall.Coronal image 77.The posterior strut penetrates 5 mm through the ivc wall.Sagittal image 87.The right strut penetrates 6 mm through the ivc wall.Coronal image 75.".
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Search Alerts/Recalls
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