Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation: the following allegations have been investigated: organ/vena cava (vc) perforation, migration, tilt, erosion, nervous, sleep loss, abdominal surgery/complications, physical limitations.Investigation is reopened due to additional information provided.The reported allegations have been further 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.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.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 erosion, nervousness, sleep loss, and abdominal surgery/complications and physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.No relevant notes on work order.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 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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Patient allegedly received an implant on (b)(6) 2011 via the right common femoral vein due to deep vein thrombosis (dvt) and pulmonary embolism (pe) post-surgery for cancer.The patient alleges migration, tilt, vena cava, and organ perforation.The patient further alleges needing abdominal surgery and complications, nervous, loss of sleep, and erosion as well as physical limitations.Exploratory laparotomy successful device retrieval on (b)(6) 2018 due to migration/perforation of the inferior vena cava.(b)(6) 2018, per a report from computer tomography; ¿summary 3.One of the anterior struts of the ivc filter is protruded slightly more through the ivc with slight surround thickening likely related to reactive change.¿ (b)(6) 2018, per a report from retrieval report (successful); ¿findings: adhesive disease within the abdomen.Erosion of the ivc filter prongs through the ivc and into the duodenal serosa.Approximately 1 hour of ivc clamp time including the renal vein.¿.
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