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Catalog Number UNKNOWN |
Device Problems
Structural Problem (2506); Device Tipped Over (2589); Detachment of Device or Device Component (2907); Insufficient Information (3190)
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Patient Problems
Internal Organ Perforation (1987); 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.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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Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2014.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 via the left internal jugular vein due to deep vein thrombosis and pulmonary embolism.Patient is alleging tilt, vena cava perforation.Report from computerized tomography (ct): "the tip of the inferior vena cave tilter is along the inner margin of the right side of the ivc and at least some of the tines have extended beyond the wall.".
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Manufacturer Narrative
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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.Catalog and lot# are unknown.The following allegations have been investigated: vena cava (vc) perforation, tilt.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: a2, a4, b1, b5, b6, b7, 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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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 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: fracture, organ perforation.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.The additional information regarding organ perforation does not change the previous investigation results for vena cava perforation.The catalog # and lot # are unknown, but the 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.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: yes.Filter tilt: yes.Filter penetration: yes.Other findings: yes.Impression: one of the filter legs is fractured from the body of the filter and is completely in the peritoneal cavity 2.2 cm anterior to the ivc and has penetrated a loop of small bowel.Axial images 40 and 41 and coronal images 15-17.A filter leg penetrates 9 mm through the posterior left wall of the ivc and into a vertebra where there are chronic reactive changes.Axial image 40 and coronal image 26.A filter leg penetrates 7 mm through the anterior right wall of the ivc.Coronal image 38.Two filter arms penetrates 5 mm through the wall of the ivc.Coronal image 23 and 25.A filter leg penetrates 12 mm through the posterior right wall of the ivc.Coronal image 26.".
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Search Alerts/Recalls
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