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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); Thrombosis/Thrombus (4440)
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Event Type
Injury
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Manufacturer Narrative
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Occupation: non-healthcare professional.Investigation: the following allegations have been investigated: organ/vc perforation.The reported allegations have been 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.Catalog number and lot number are unknown.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.
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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 an unknown date and multiple struts of the filter perforated outside of the vena cava, including at least one strut that punctured the duodenum.Hospital and medical records have been requested, but not yet provided.
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Event Description
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Patient is alleging tilt, vena cava/organ perforation, and chronic thrombus.The patient further alleges anxiety.Report from ct (computed tomography): "there is an ivc filter which the limbs a pear to penetrate through the wall of the ivc and appears to be in the duodenum.This is nontraumatic and there is no surrounding free fluid or inflammatory change.".
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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: thrombus, tilt, anxiety.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 anxiety is 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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