The device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
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(b)(4) clinical study.It was reported that embolization occurred.In (b)(6) 2018, the patient's qualifying condition was rutherford category 3 and on the same day, the index procedure was performed.The target lesion was located in the right superficial femoral artery (sfa) had 80% stenosis, reference vessel diameter of 4mm, a length of 50mm and was classified as a tasc ii a lesion.Target lesion was treated with pre-dilatation using 4 mm x 60mm coyote balloon catheter and standard percutaneous transluminal angioplasty (pta) was performed with a 5mm x 60mm coyote balloon.Following this intervention, distal embolization was noted.Post dilatation was not performed.Charger balloon was used to treat the target lesion.On the same day of the index procedure, right lower extremity angiogram revealed distal embolization of the sfa with acute closure of right popliteal artery post treatment with standard pta using coyote balloon.Penumbra indigo cath 3 aspiration thrombectomy was performed with the advancement to the popliteal artery to treat this event.Post intervention, final residual stenosis was noted to be 10%.Repeat angiography revealed resolution of the embolus and the event was considered to be recovered/resolved.On the next day, the patient was discharged on aspirin and clopidogrel.
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