The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The device history record for the reported oad was unable to be reviewed, as the lot number was not provided.(b)(4).
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During a procedure with a peripheral orbital atherectomy device (oad), slow flow and no reflow occurred due to embolization of the lesions.The target lesions were a 110 mm chronic total occlusion located proximal through distal in the superficial femoral artery (sfa) and popliteal artery (pop), and a 40 mm chronic total occlusion located in the distal anterior tibial artery (at).All lesions were severely calcified.During the procedure, there were complications with the lesions including embolization, slow flow, and no flow.The physician's opinion was the embolization was a result of orbital atherectomy and no distal outflow.The lesions were stented, and the procedure was halted.The patient lost color and pulse in the foot, and the patient was admitted for monitoring as amputation was considered.Color and pulse returned to the foot, and the patient was discharged home.The oad reported to have performed as expected.
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It was reported on (b)(6) 2019 that the patient still had a pulse signal in their foot and peroneal artery, but they had bilateral wounds on their feet and a below-the-knee amputation was planned.The oad reported to have performed as expected and had a large orbit in the sfa during the initial procedure.On (b)(6) 2019, it was reported that the below-the-knee amputation had occurred successfully.
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