The patient developed vte (venous thromboembolism); arterial occlusion of the left lower extremity following "treatement" with ekos for a bilateral pe.The investigator assessed the vte (venous thromboembolism); arterial occlusion of the left lower extremity as serious and not related to the ekos device but probably related to the interventional procedure, thrombolytic drug and anticoagulant drug.The study's medical monitor assessed the sae as definitely related to the interventional procedure and not related to the ekos system, thrombolytic drug and anticoagulant drug.The btg physician is in agreement with the study's medical monitor.As the event is not related to the device, no investigation into the device history record is required.Distal embolization of blood clots is listed in the ifu as a potential complication [associated with the procedure].No additional information will be available.
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