Additional information: investigation.Investigation is reopened due to additional information provided.The following allegations have been investigated: pulmonary embolism ,vena cava perforation, deep vein thrombus ,tilt, pain, physical limitation, depression ,anxiety, worry, medication, sleeplessness.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.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 pain, physical limitation, depression, anxiety, worry, medication, sleeplessness are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Twenty 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 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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Patient allegedly received an implant via the right common femoral vein due to pulmonary embolism (pe) and deep vein thrombosis (dvt).Patient is alleging tilt and vena cava perforation.Patient further alleges pain, physical limitations, depression, anxiety, worry, medication, sleeplessness, and post-implant pe and dvt.Report from computerized tomography (ct): "positive for caval perforation.Superior extend of filter is at l2-l3 disc space.Inferior extent mid l4 vertebral body.A total of four prong have perforation through ivc, series 3, image 70.Maximum distance prong perforated through ivc is 6.80mm, series 3, image 70.Coronal images show 3.89-degree tilt of filter right to left, series 4, image 34.Sagittal image show 4.85 degree tilt posterior to anterior series 5 image 53.Diameter of ivc directly above filter measures 20-17 mm x 16.38 mm series 3, image 54.".
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