This additional information received on 10/24/2017 as follows: patient received an implant on (b)(6) 2008 via the right common femoral vein due to trauma.Patient experiences filling defects within the filter consistent with thromboembolic material and is approximately 50% of the filter volume and therefore the filter was not removed.Patient is alleging bleeding, chest pain, bowel bleeding and fear due to the device.Retrieval was attempted on (b)(6) 2008.
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Manufacturer reference # (b)(4).Exemption number e2016032.(b)(4).Corrected data based on new information received: product problem to adverse event and product problem, to life threatening, malfunction to serious injury.It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'celect, occlusion, unable to retrieve, bleeding, chest pain, bowel bleeding, fear'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature.Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging or venography; this may be symptomatic or asymptomatic.Unknown if the reported bleeding, chest pain, bowel bleeding, fear is directly related to the filter and unable to identify corresponding failure mode(s) at this time.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.
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