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Catalog Number UNKNOWN |
Device Problems
Inadequate Filtration Process (2308); Obstruction of Flow (2423); Structural Problem (2506); Detachment of Device or Device Component (2907); Unintended Movement (3026)
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Patient Problems
Pulmonary Embolism (1498); Fatigue (1849); Internal Organ Perforation (1987); Perforation of Vessels (2135); Stenosis (2263); Obstruction/Occlusion (2422); 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: fracture and organ/ vena cava perforation.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.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.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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The following information is alleged: the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2008.Approximately 12 years and 4 months later, the patient underwent a computed tomography (ct) scan which revealed that the filter had perforated the ivc wall with a prong protruding into the right iliopsoas muscle belly and adjacent prongs in close proximity to adjacent bowel and aorta with one or more struts fracturing.Hospital and medical records have been requested, but not yet provided.
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Manufacturer Narrative
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Investigation the following allegations have been investigated: pulmonary embolism (pe), occlusion/blood clot/thrombus/stenosis, migration, shortness of breath (sob), chest pain, exhaustion, limited lifting.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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.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.Unknown if the reported shortness of breath (sob), chest pain, exhaustion, and limited lifting 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; however, the alleged filter is manufactured and inspected according to controls.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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Patient allegedly received an implant on (b)(6) 2008 via the right internal jugular vein due to post pulmonary embolism.The patient alleges migration, vena cava perforation, fracture, and stenosis.The patient further alleges shortness of breath (sob), chest pain, easily tired, and limited lifting.(b)(6) 2009, per a report from computed tomography; "findings: within the upper abdomen a caval filter is noted in the suprarenal ivc.A small quantity of thrombus is seen above the filter and a larger thrombus extends from the distal ivc into the right atrium adjacent to the interatrial septum.The filter and 2 thrombi described were not present on prior exam ¿impression: bilateral predominantly central \e\t\e\ lower lobe filling defects which have decreased in amount and have the appearance of more chronic appearing emboli.Specific evidence of superimposed acute emboli are not identified but there has been development of thrombus in the ivc and right atrium as well as just above the internally placed caval filter.No evidence of right ventricular strain is identified.The nonspecific parenchymal opacity seen previously have improved.The lack of thrombus below the filter suggests that the caval and ra thrombi are in situ.¿ (b)(6) 2020, per a report from computed tomography; ¿impression: 1.Complete chronic occlusion of the bilateral external iliac veins and inferior vena cava beneath the ivc filter.2.Suprarenal ivc filter notable for fractured and displaced prong in the right iliopsoas muscle belly and adjacent prongs in close proximity to adjacent bowel and aorta without discrete violation.¿.
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Event Description
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06oct2020, per a report from computed tomography 2; ¿impressions: the ivc is collapsed around the filter which is consistent with chronic ivc stenosis.The ivc distal to the filter is very stenotic.As a result of this, there are large varicose veins seen in the soft tissues of the abdomen.The entire filter is above the renal veins.It is in the hepatic segment of the ivc.It may have been placed high or may have migrated to this position.A high position of the filter puts the patient at risk for renal vein thrombosis and renal failure if the ivc becomes thromboses.The anterior strut penetrates 9 mm through the ivc wall.It penetrates into the duodenum.The left strut penetrates 11 mm through the ivc wall.The posterior strut penetrates 25 mm through the ivc wall.The entire leg is fractured from the body of the filter and has penetrates into a vertebra where there are chronic reactive changes.The right strut penetrates 4 mm through the ivc wall.¿.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation.The following allegations have been investigated: large varicose veins.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 large varicose veins 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; however, the alleged filter is manufactured and inspected according to controls.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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