(b)(4).Catalog#: unknown but referred to as a cook celect filter.Name and address for importer site: (b)(4).Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.(b)(4).It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating ¿celect filter implanted".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.
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Blank fields on this form indicate the information is unknown or unavailable, or unchanged.Exemption number (b)(4).Lot.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Mfr site name and address for importer site: cook medical incorporated (cmi) (b)(4).Registration no.: (b)(4).Additional information: investigation it has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'celect, unable to retrieve (in place 90 days)'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.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.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.Device evaluated by mfr : blank fields on this form indicate the information is unknown or unavailable, or unchanged.Exemption number e2016032e lot.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Mfr site name and address for importer site: cook medical incorporated (cmi) (b)(4).Registration no.: (b)(4).Additional information: investigation it has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'celect, unable to retrieve (in place 90 days)'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.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.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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Device code(s): appropriate term/code not available (3191) was selected for the alleged device perforation and tilt.Investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava (vc) perforation, thrombosis, migration, tilt, fear, physical limitations.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.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.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.Unknown if the reported fear and physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.The following allegations have been investigated: vena cava (vc) perforation, thrombosis, migration, tilt, fear, physical limitations.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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Patient allegedly received an implant on (b)(6) 2014 due to venous thromboembolic.Patient is alleging migration, tilt, vena cava perforation, filter in place more than 90 days.Patient further alleges future risk, physical limitations, thrombosis x 2 and fear.Report from computerized tomograph (ct): "inferior vena cava filter located in inferior vena cava.Perforation of several struts of the inferior vena cava.Tilt of the inferior vena cava filter posteriorly laterally with tip of the inferior vena cava near the inferior margin of right renal vein.".
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