Patient allegedly received an implant on (b)(6) 2012 via the right common femoral vein prior to bariatric surgery.Patient is alleging vena cava perforation.Patient notes and further alleges experiencing "left leg discomfort, back discomfort, loss of feeling left leg, loss of strength in leg" and physical limitations.Per an (b)(6) 2018 computed tomography (ct) abdomen: "the ivc is normal in caliber.A solitary ivc filter is present and is located distal to the origin of the renal veins.The ivc filter is intact without strut fracture or ending.Several of the struts, however, do appear to be located outside of the ivc wall.The filter is tipped medially along the long axis".
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava perforation, tilt, leg/back discomfort, loss of feeling/strength in leg, physical limitations.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/back discomfort, loss of feeling/strength in leg, 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, one other unrelated complaint has 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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