The previous medwatch report was submitted by william cook europe under manufacturer report reference# 3002808486-2019-01757.Additional information provided determined that this device was manufactured by cook inc.With the submission of this initial medwatch report, cook inc.Informs that all future submissions regarding this complaint will be handled under the manufacturer report reference # referenced in this initial medwatch report.Initial reporter occupation: non-healthcare professional.(b)(4).Investigation: the investigation was reopened due to additional information provided.The following allegations have been investigated: vena cava perforation, migration, discomfort, pain, and 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 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 discomfort, pain, and physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.To date, no other complaints have 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 current controls.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.
|
Patient allegedly received an implant on (b)(6) 2014 via the right common femoral vein post pulmonary embolism (pe).Patient is alleging migration and vena cava perforation.The patient is further alleging discomfort, pain, and limitations/ inability to engage in "work lifting, bending, climbing." per a report from ct (computed tomography), "half of the filter is seen proximal to the renal veins.The proximal cone of the filter is 3 cm above the renal veins.The body of the filter crosses the origin of the renal veins.The filter was either originally placed higher than normal or it migrated to its current position.The legs of the filter have penetrated through the wall of the ivc into the pericaval/ mesenteric fat.".
|