Patient had an ultrasound of her right leg during outpatient visit with cardiology which indicated subacute dvt of the popliteal vein and she had scheduled elective venography at (b)(6) 2022.The procedure was carried out through pedal access using dorsalis pedis vein and anterior tibial vein, which confirmed the findings of the dvt in right popliteal vein with extension into the distal right superficial femoral vein.Several rounds of aspiration thrombectomy and balloon venoplasty was carried out with some improvement in the flow, although the vein recoiled and there was still complete occlusion, therefore, pharmacomechanical thrombolysis catheter was placed overnight to infuse 0.5 mg of tpa per hour along with heparin and ekos catheter was placed.This catheter was removed the next day, (b)(6) 2022, and follow-up venography indicated complete resolution of the clot, although it also indicated a broken piece of the distal tip of the ultrasound core of the ekos catheter that was subsequently retrieved using a snare.On the day of discharge, the patient had a complete normal venous return with resolution of the thrombus in the right popliteal vein.Found under venography.Fda safety report id# (b)(4).
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