WILLIAM COOK EUROPE COOK CELECT JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Catalog Number IGTCFS-65-JUG-CELECT-PERM |
Device Problems
Structural Problem (2506); Unintended Movement (3026); Insufficient Information (3190)
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Patient Problems
Edema (1820); Pain (1994); Perforation of Vessels (2135); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturer ref# (b)(4).Catalog# is unknown but referred to as cook celect filter.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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Description of event according to short forms complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2010.It is alleged that the [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.".
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Event Description
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Patient allegedly received an implant on (b)(6) 2010 via the right internal jugular due to thrombophlebitis.Patient is alleging tilt and vena cava perforation.Patient further alleges chronic lower back pain/abdominal pain, lower limb edema, discomfort, physical limitations, trouble walking, trouble standing.
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Manufacturer Narrative
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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 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 pain, edema, discomfort, physical limitations, trouble walking, and trouble standing are directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) devices in lot.No relevant notes on work order for device.No other complaints on lots.The following allegations have been investigated: vena cava (vc) perforation, tilt, pain, edema, discomfort, physical limitations, trouble walking, trouble standing.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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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, 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.Cook will reopen the investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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 medical opinion: "ivc filter is infrarenal in position.No ivc filter fracture noted.The anterior most filter strut is seen piercing the anterior wall of ivc (27.53 mm) and impinging the duodenum anteriorly.The medial filter strut is seen piercing the medial wall of ivc (26.40 mm) and is seen lying adjacent/ impinging the aorta.The posterior filter strut is seen piercing the posterior wall (17.89 mm) and is seen impinging the prevertebral structures.The lateral filter strut is seen piercing the lateral wall (14.74mm).Anterior tilt (22.92 deg) of the ivc filter is noted.No ivc filter fracture noted".
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Search Alerts/Recalls
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