Report from computerized tomography (ct): "an ivc filter terminates with apex midline at the l1-l2 level, below the renal vein confluence, at the distal margin, the struts extend beyond the lumen of the ivc but with the anterior strut on the left in close proximity to peripheral atherosclerosis surrounding the nondilated abdominal aorta." "ivc filter is appropriate position with distal struts extending slightly beyond the lumen of the ivc.".
|
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: investigation 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.Catalog and lot# are unknown.The following allegations have been investigated: vena cava perforation.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.The following fields were updated per additional information received: a2, b1, b5, b6, b7, h6.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.
|