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WILLIAM COOK EUROPE COOK CELECT JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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| Model Number G48372 |
| 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); Perforation (2001); Perforation of Vessels (2135); Anxiety (2328); Device Embedded In Tissue or Plaque (3165)
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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.(b)(4).Summary of investigational findings: the reported allegations have been 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.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.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 "on or about (b)(6) 2010, [pt] was implanted with a cook celect filter.[pt]'s cook celect filter subsequently malfunctioned and caused injury and damages to [pt], which included perforation, tilt and migration.Specifically, [pt] suffered a grade 4 perforation of 9 o'clock strut into duodenum and 12 o'clock strut into duodenum as well as grade 3 perforations of 5 and 6 o'clock struts to abut l3 vertebral body and grade 4 perforation of 6 o'clock strut into right psoas muscle.The celect filter had tilted 19.4 degrees of coronal tilt with apex of filter abutting the posterior wall of left renal vein confluence with migration of apex of filter at level of left renal vein confluence.Furthermore, he suffered fractured posterior struts." patient outcome: unknown.
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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.Unknown if the reported anxiety is 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 wo for neither device (igtcfs-65-jug-celect-perm).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, anxiety.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 tilt, vena cava perforation, fracture, organ perforation.Patient further alleges anxiety.Report from computerized tomography (ct): "superior extent of filter is at the mid l2 vertebral body.Inferior extent inferior l3 vertebral body.A total of six prongs have perforated the ivc, series 2, image 35.Maximum distance prong perforated is 13 mm, series 2, image 36.Coronal images show 16-degree tilt of filter right-to-left, series 301, image 44.Sagittal images show zero-degree tilt, series 300, image 69.Diameter of ivc directly above filter measures 30 mm x 25 mm, series 2, image 28.".
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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Manufacturers ref# (b)(4).This report is required by the fda under 21cfr 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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Corrected information: d4 (model #).Additional information: b5, b6, h6.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: embedment.The additional information regarding embedment does not change the previous investigation results for organ/vena cava perforation.(b)(4) 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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Per additional information received: per a report from ct: "there is an ivc filter in place which likely represents a celect type filter.The filter is tilted approximately 20° towards the left with respect to the long axis of the ivc.The upper tip of the filter is located at the confluence of the left renal vein and ivc and partially crosses the right renal vein confluence.The ivc is mildly distended at this level.All 4 of the larger metallic struts project beyond the confines of the ivc.The posterior strut extends up to 2 cm beyond the ivc wall and is in close proximity to the anterior margin of the l3 vertebral body.There is a smaller linear density along the distal aspect of the strut on series 2, image 36 which may represent broken wire fragment.A transversely oriented wire measuring at least 6 - 7 mm on series 2, image 33 - 34 may also represent broken wire.The posterior and medial strut contacts the anterior superior margin of l3 with surrounding bony hypertrophy and sclerosis.This may be partially embedded.The lateral strut extends at least 1.6 cm outside of the ivc and may protrude into the 2nd portion of the duodenum".Per a report from ct: "caval perforation: yes.Grade 4 perforation of 9 o'clock strut into duodenum and 12 o'clock strut into duodenum.Grade 3 perforations of 5 and 6 o'clock struts to abut l3 vertebral body.Grade 4 perforation of 6 o'clock strut into right psoas muscle.Tilt: yes.19.4 degrees of coronal tilt.No substantial sagittal tilt.Apex of filter abuts posterior wall of left renal vein confluence.Migration: yes.Apex of filter at level of left renal vein confluence.Pertinent negatives: no ivc stenosis visualized.Additional findings: suggestion of fractured distal posterior strut on series 2, images 33 and 34 as well as fractured posterior strut immediately posterior to the 6 o'clock rightward strut".
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