Patient allegedly received an implant on (b)(6) 2013 via the right common femoral vein due to trauma.Patient is alleging tilt, vena cava and organ perforation, and embedment.The patient further alleges pain and physical limitations.Per a (b)(6) 2018, report from ct (computed tomography): "filter is tilted approximately 17 degrees to the right lateral wall of the ivc.The apex is embedded in the wall.But does not extend beyond the wall.Filter tip is located approximately 1 cm above below the lowest renal vein; one of the inferior struts posteriorly perforates 2 mm beyond the wall into the psoas muscle.A second inferior struts in the right ventral ivc is just embedded at the wall.A third inferior strut perforates 2 mm and contacts the aortic wall but does not appear to penetrate through it.The fourth most inferior strut on the left perforates 5 mm beyond the vc wall and is actually embedded within an osteophyte of the vertebral body at l3.It extends to the level of the inferior endplate.There is no fracture or abnormal bending of the struts.No stenosis of the ivc.".
|
Investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: vena cava/organ perforation, embedment, tilt, pain, physical limitations.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 pain, 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 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.
|