Patient allegedly received an implant on (b)(6) 2015 via the right femoral vein due to deep vein thrombosis (dvt) and pulmonary embolism (pe).Patient is alleging device tilt and strut perforation.Patient notes and also alleges experiencing "blurred vision, off balance, dizzy, memory loss, numbness".Per the ct abdomen without contrast dated (b)(6) 2019: ivc filter evaluation: "filter tilt: the ivc filter is tilted along the course of the patient's ivc.The apex of the filter is touching the posterior ivc wall.Abnormal positioning of the ivc filter: the ivc filter tip is located below the lowest renal vein and not greater than 2 cm below the lowest renal vein.Perforation beyond the ivc wall with or without involvement of an adjacent organ/vessel: the anterior left and right filter struts extend 4 mm beyond the wall of the ivc, both touching the adjacent third portion of the duodenum without appearing to extend through the wall.Filter strut fracture or bending: no fractured or bent strut fragments identified.Stenosis of the inferior vena cava: no ivc stenosis identified by noncontrast ct".
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Investigation is reopened due to additional information provided.The following allegations have been investigated: strut perforation, tilt, blurred vision, off-balance, dizziness, memory loss, and numbness.Vena cava wall penetration/perforation has been reported and 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 blurred vision, off-balance, dizziness, memory loss, and numbness are directly related to the filter and unable to identify a corresponding failure mode at this point in time.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 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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