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Catalog Number UNKNOWN |
Device Problems
Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589)
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Patient Problems
Internal Organ Perforation (1987); Perforation of Vessels (2135); Anxiety (2328); Depression (2361); Thrombosis/Thrombus (4440)
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Event Type
Injury
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Manufacturer Narrative
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Initial reporter occupation: non-healthcare professional investigation: the reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: vena cava perforation.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.Catalog number and lot number are unknown.The alleged tulip 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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The following information is alleged: the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2004.Approximately 14 years and 6 months later the patient underwent a computed tomography scan which revealed that the filter had moved since its implantation as several struts of the filter were perforating through the ivc wall.Hospital and medical records have been requested, but not yet provided.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 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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The patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2004.
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Event Description
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Patient allegedly received an implant on (b)(6) 2004 via the right internal jugular vein due to deep vein thrombosis (dvt) and pulmonary embolism (pe).Patient is alleging tilt, vena cava perforation, dvt, and caval thrombosis.The patient further alleges fear, depression, anxiety, and physical limitations.Report from ct (computed tomography): "there is a filter in the ivc.There is a sausage-shaped filling defect in the ivc well below the filter, 4 cm long, up to 1 :4 cm in diameter.There is also a lack of opacification of the dilated right common, internal and external iliac veins, suggesting thrombosis.The left iliac veins appear widely patent." report from ct of abdomen/pelvis: "again seen is probable thrombosis involving the right common, internal and external iliac veins.Clot extends into the ivc below the level of the filter.The ivc clot appears slightly increased from the prior study, but is not occlusive." radiology report: "ivc filter with: 5 mm mesenteric perforation.Tilting with the apex against the wall.No fracture, migration, or stenosis.".
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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.The following allegations have been investigated: organ perforation, caval thrombosis/deep vein thrombosis (dvt), tilt, fear, depression, anxiety, physical limitations.The additional information regarding organ perforation does not change the previous investigation results for vena cava perforation.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 fear, depression, anxiety, and physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog number and lot number are unknown.The product 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 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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Search Alerts/Recalls
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