The physician intended to use the use the hawkone lx 7f, to treat a 450 mm fibrous plaque lesion with 90% stenosis, in the right superficial femoral artery and popliteal artery.Artery diameter was 6 mm.It was reported the physician used a contra lateral approach, with 7fr non medtronic sheath.It was reported the sfa was diffusely diseased about 90-99% in the entire sfa with a healthy popliteal artery.A 6x40 non-medtronic stent was used from the ostium of sfa and 6x150 non-medtronic stent in the hunters canal extending to popliteal.A guide catheter and stiff 0.035 guidewire was used to cross sfa, then it was exchanged for a 0.014 non medtronic 300 mm wire.The h1-lx was prepped per ifu with no visible damage noted and inserted into the patient to treat the entire sfa.After several passes were made, the nosecone was filling up and the physician started to feel a little resistance when packing the device.The catheter was safely removed for cleaning.After cleaning was performed per ifu, the catheter was inspected and no visible damage was noted.The device was turned on and off several times to inspect the cutter blade and it was reported to have been working properly.The catheter was re-inserted into the patient.After making several passes the physician felt the same resistance closing the thumbswitch and the nosecone was not packing and the catheter was removed for inspection.On removal from the sheath, a hole in the nosecone was noted with plaque protruding out of it.An angiogram confirmed embolization of the plaque protruding through the nosecone into the anterior tibial (at) and occluding outflow distally.Aspiration was performed to remove the plaque that embolized into anterior tibial.Once flow was re-established in the at, the procedure was completed using an in.Pact admiral dcb to treat the sfa/ popliteal.An angiogram confirmed that the outflow was established and the procedure was successfully completed.No further patient injury was reported.
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