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
Structural Problem (2506); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problems
Abdominal Pain (1685); Nausea (1970); Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165); 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) 2013".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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Appropriate term/code not available (3191) for alleged device perforation.Appropriate term/code not available (3191) for alleged device tilt.Investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava perforation, tilt, abdominal pain, nausea, headache, mental distress, limited mobility/physical activity.The reported allegations have been further investigated based on the information provided to date.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 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 abdominal pain, nausea, headache, mental distress, limited mobility/ physical activity is directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.No other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device 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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Event Description
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Patient allegedly received an implant on (b)(6) 2013 via the right common femoral vein due to deep vein thrombosis (dvt) and pulmonary embolism (pe).Patient is alleging device tilt, vena cava perforation, nausea, severe pain in abdominal area radiating to lower back, mental distress about future complications.Patient notes and further alleges experiencing "headaches and inability to sit, stand or lay down for long periods of time".Patient further alleges limits to physical activity.Per the (b)(6) 2019 ct abdomen: "impression: "there is an ivc filter in place.The filter has a 13 degree tilt to the left and the coronal images.The tip of the filter protrudes through the left lateral wall of the ivc.All 4 of the struts of the filter protrude to the walls of the ivc consistent with grade 2 perforation's.No fracture of the struts is appreciated".
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Event Description
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Per additional information received: per the addendum to the ct scan 14jan2019: "addendum: the filter is tilted anterior left with it¿s cone embedded in or slightly through the ivc wall, axial image 13/51.Some of the filter struts penetrate through the wall of the ivc as follows: right lateral strut: 11mm, coronal image 58/102.Anterior strut: 4 mm, sagital [sic] image 69/132.
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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: b5, b6, h6 (patient and device codes) investigation: 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: embedded.The additional information regarding embedded does not change the previous investigation results for vena cava perforation.(b)(4) devices in lot.To date, no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device 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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