WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Catalog Number IGTCFS-65-1-FEM-CELECT-PT |
Device Problems
Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Perforation of Vessels (2135); Thrombosis/Thrombus (4440); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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It has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.Catalog # is unknown but referred to as celect.Occupation: non-healthcare professional.Catalog number and lot number are unknown, however, the alleged celect 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.
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Event Description
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Original: it is alleged that the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2017, and the patient 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) 2017 via the right common femoral vein due to deep vein thrombosis.Patient is alleging tilt, vena cava perforation.Patient further alleges palpitation, chest pain, abdomen pain, vessel spasms.Report from ct: "patient has a recovery series type infrarenal ivc filler.The filter tip is cranial and almost abuts the anterior wall of the vena cava ivc struts are intact and almost all the struts are seen piercing through the vena cava walls.There is no invasion of adjacent structures.No migration of the filter is seen.Limited visualization.".
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Manufacturer Narrative
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Additional information: h6 (patient and device codes).Investigation is still in progress.A follow up report will be submitted upon it's conclusion.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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No additional reportable event information has been provided.
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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: h6.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.The following allegations have been investigated: vena cava (vc) perforation, deep vein thrombosis (dvt), tilt, palpitations, pain, spasms.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 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 palpitations, pain, and spasms are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 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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Manufacturer Narrative
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The following fields were updated per additional information received: b5, b6, and 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.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 celect.Ivc stenosis: no.Filter position: below above the renal veins.Filter migration: none.Filter fracture/bending: no.Filter tilt: no.Filter penetration: yes.Other findings: no.Impressions: the filter is not tilted but the cone of the filter is against the anterior wall of the ivc.Axial image 80.The anterior strut penetrates 4 mm through the ivc wall.Sagittal image 63.The left strut penetrates 7 mm through the ivc wall.Coronal image 47.The posterior strut penetrates 7 mm through the ivc wall.Sagittal image 68.The right strut penetrates 9 mm through the ivc wall.Coronal image 52.".
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Search Alerts/Recalls
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