(b)(4).Article: excessive venous bleeding in a patient with acetabular pelvic fracture secondary to inferior vena cava filter occlusion.Nahas et al, 2012.Bmj case rep.2012 nov 30;2012.Pii: bcr2012006712.Doi: 10.1136/bcr-2012-006712.Catalog# is unknown but referred to as cook celect filter.Since catalog# is unknown 510(k) could be similar to either k061815, k073374, k090140, k112119, k121057 or k121629.(b)(4).Investigation is still in progress.
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Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on article and image review.Patient suffered a complex pelvic fracture, while abroad, resulting in a 14 day delay in surgical intervention.In the preoperative period, patient developed pulmonary emboli and was started on heparin as well as treated with an ivc filter inserted prior to surgery.On the day of surgery, one day following insertion of the ivc filter, the heparin was stopped.During the surgical exposure, the operating physicians encountered ¿torrential bleeding¿ and the surgery was abandoned with the wound packed for hemorrhage control.Ct angiogram was performed immediately following the surgery did not demonstrate any large vascular injury, but did demonstrate an expansile appearance to the ivc and iliac veins, as well as retroperitoneal edema, findings which suggest acute thrombosis of the ivc and iliac veins.The celect filter demonstrated no significant tilt and no penetration.Unfortunately, the phase of contrast enhancement was not ideal for evaluation of the inferior vena cava and pelvic deep venous thrombosis, however, given the expansile appearance, this is highly suspicious for complete thrombosis.There was no preoperative ultrasound performed of the lower extremities to evaluate current dvt.It is hypothesized by the author that the manipulation of the femoral vessels may have dislodged a dvt resulting in acute occlusion of the ivc at the level of the filter.Given that the patient was anticoagulated up until the time of surgery and the surgery was performed one day after placement of the ivc filter, it is very unlikely that the filter acted as a nidus for ivc thrombosis, but rather performed the intended function by preventing migration of dvt to the pulmonary arteries.The consequence of this function resulted in the acute occlusion of the ivc, and therefore contributed to the elevated venous pressures and extensive bleeding encountered during surgery.It is well-established that ivc filters decrease the risk of symptomatic pulmonary emboli, at the cost of increasing the risk of lower extremity in caval thrombosis over time.However, given the sequence of events and timeframe discussed in this case report, the more likely explanation is the filter performed its intended function.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.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 medical will continue to monitor for similar events.
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