Additional information received identified the patient allegedly received a cook celect femoral and jugular vena cava filter implant on (b)(6) 2009 via the right common femoral vein due to deep vein thrombosis and pulmonary embolism with hemoptysis.The patient is alleging migration and vena cava perforation.The patient further alleges constant abdominal pain and the inability to do outside homecare and yard work.Per the (b)(6) 2017, computed tomography-abdomen and pelvis without contrast: "non-contrast evaluation of the vascular structures demonstrates an inferior vena cava filter within the infrarenal inferior vena cava.A few of the legs appear extracaval, similar to prior.There is mild atherosclerotic calcification of the aorta and its branches.No suspicious lymphadenopathy is identified".
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Investigation ¿ investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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 or filter fragment migration and (or) embolization (e.G., movement to the heart or lungs) has been reported.Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; 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: filter migration, trauma to adjacent structures.Unknown if the reported abdominal pain, disability is directly related to the filter and unable to identify a corresponding failure mode at this time.The following allegations have been investigated: migration, vc perforation, abdominal pain, disability.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.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.
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