Occupation: non-healthcare professional.(b)(4).Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: perforation, lifelong anticoagulants, anxiety, upcoming surgery, physical limitation.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.Unknown if the reported lifelong anticoagulants, anxiety, upcoming surgery, physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of 20 devices were manufactured in the reported lot.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 via the right internal jugular vein due to deep vein thrombosis.Patient is alleging vena cava perforation, organ perforation, perforation of aorta and lifelong anticoagulants.Patient further alleges anxiety, upcoming surgery, physical limitations.Report from computerized tomography (ct): "there is a gunther type ivc filter in place in the inferior vena cava.The filter appears vertically oriented and the upper tip is located approximately 2 cm below the confluence of the ivc and renal vein.The larger metallic struts project outside of the ivc wall by up to 1 cm in length and 3-4 mm in the transverse plane.A left sided strut is located along the outer surface of the aorta.".
|