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Catalog Number UNKNOWN |
Device Problems
Inadequate Filtration Process (2308); Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pulmonary Embolism (1498); Stroke/CVA (1770); Myocardial Infarction (1969); Nerve Damage (1979); Internal Organ Perforation (1987); Perforation of Vessels (2135); Anxiety (2328); Depression (2361); Thrombosis/Thrombus (4440); Unspecified Heart Problem (4454); 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 gunther tulip.Occupation: non-healthcare professional.Catalog number and lot number are unknown, however, 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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Original.It is alleged that the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2014, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.
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Manufacturer Narrative
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Additional information: investigation.The investigation was 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: pulmonary embolism, vena cava perforation, thrombosis (caval thrombosis/dvt), tilt, nerve damage, heart attack, stroke, thurner syndrome, physical limitations, breathing difficulty, cognitive skills limited, depression, anxiety, poor health.New pe 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: pulmonary embolism.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 nerve damage, heart attack, stroke, thurner syndrome, physical limitations, breathing difficulty, limited cognitive skills, depression, anxiety, and poor health 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 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 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 on (b)(6) 2014 via the right common femoral vein due to pulmonary embolism.Patient is alleging tilt, vena cava perforation, caval thrombosis, and pulmonary embolism (pe).Patient is further alleging post implant deep vein thrombosis (dvt), nerve damage (left foot [completely] numb), possible mild heart attack, light stroke, thurner syndrome, limited motor skills/ function, breathing difficulty, cognitive skills limited, depression, anxiety, and overall poor health.Per a report from computerized tomography (ct): "an ivc filter is positioned below the level of the renal veins.The filter is tilted anteriorly 13 [degrees].There is no bending or breaking of the device.Posteriorly, the distal struts extend beyond the vessel wall.There is no ivc stenosis." per a report from ct: "an infrarenal ivc filter is noted.The ivc is distended from the level of the ivc filter through the bilateral common iliac veins with adjacent inflammatory change likely indicating diffuse ivc thrombus.".
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Event Description
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Report from ct (computed tomography): "filter type: cook gunther tulip.Ivc stenosis: no.Filter position: below the renal veins.Filter migration: none.Filter fracture/bending: no.Filter tilt: no.Filter penetration: yes.Other findings: yes.Impressions: the filter is not tilted but the cone of the filter is against the anterior wall of the ivc.Axial image 33.The anterior right strut penetrates 7 mm through the ivc wall.It penetrates into the duodenum.Sagittal image 45.The anterior left strut penetrates 8 mm through the ivc wall.It penetrates into the duodenum.Sagittal image 41.The posterior right strut penetrates 10 mm through the ivc wall.Sagittal image 45.The posterior left strut penetrates 10 mm through the ivc wall.It penetrates into a vertebra where there are chronic reactive changes.Sagittal image 41.Axial image 43.".
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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.The following allegations have been investigated: organ perforation.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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Search Alerts/Recalls
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