The previous medwatch report was submitted by william cook (b)(4) under manufacturer report reference#3002808486-2021-00973.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.Reporter occupation: non-healthcare professional.Investigation: the following allegations have been investigated: organ/vena cava perforation, tilt, pain, anxiety/depression, limited mobility.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 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, anxiety/depression, limited mobility are directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) 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 becomes available.
|
Patient allegedly received an implant on (b)(6) 2014 via the right femoral vein due to prevention of deep vein thrombosis/pulmonary embolism.The patient alleged tilt, vena cava perforation, organ perforation, and pain.The patient further alleged anxiety, depression, and limited mobility.On (b)(6) 2019, per a report from computed tomography; ¿vasculature: there are aortic calcifications.There is tortuosity in the upper abdominal aorta.There is an ivc filter with the tip at the left renal vein confluence with the ivc.There is mild leftward tilt of approximately 14 degrees.The medial strut abuts the right lateral wall of the aorta.This is approximately 2 mm external to the wall of the aorta.No definite strut fracture is seen.Ivc size is normal.¿.
|