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 this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements prior to distribution.Csi id: (b)(4).
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A diamondback peripheral orbital atherectomy device (oad) was used to treat a lesion in the common femoral artery (cfa) and a chronic total occlusion in the superficial femoral artery (sfa).Following balloon angioplasty and stent placement in the sfa, atherectomy was performed in the cfa on low and medium speeds.A treatment pass was performed on high speed in the cfa and the crown engaged the proximal sfa, resulting in an embolus of calcified material traveling down stream.Distal flow was occluded, and a filter device was used to remove a portion of the embolus.There was a visible embolism in the tibial vessels, and a catheter was placed for tissue plasminogen activator (tpa) therapy.The tpa therapy was performed overnight, following which the patient was in stable condition with continued leg ischemia.On (b)(6) 2020, a bilateral fasciotomy and thrombectomy was performed.The patient was in stable condition following the procedure and was discharged.
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