Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: a2, a4, b1, b5, b6, b7, d1, d4, g5, h4, h6 (patient and device codes) investigation: the following allegations have been investigated: organ/vena cava (vc) perforation, tilt, leg swelling, feeding tube, warfarin poisoning, stomach ulcers, stomach pain, abdominal distention/feeling of fullness, nerve damage, and 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 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 leg swelling, feeding tube, warfarin poisoning, stomach ulcers, stomach pain, abdominal distention/feeling of fullness, nerve damage, 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.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 report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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 internal jugular vein due to deep vein thrombosis (dvt).Patient is alleging device tilt, vena cava and organ perforation.Patient notes and further alleges experiencing "persist leg swelling, feeding tube, warfin [sic] poison, stomach ulcers, gi problems, severe stomac [sic] pain, extended adbomden [sic], nerve damage a constant feeling of fulliness [sic]" as well as physical limitations.Per the (b)(6) 2019 ct chest, abdomen, and pelvis with intravenous contrast: "ivc filter with tilting and vertebral perforation.No fracture, migration or stenosis".
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