H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that chest pain and vessel occlusion are potential adverse events that may occur and/or require intervention with use of the system.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.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.Csi id: (b)(4).
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A diamondback 360 coronary orbital atherectomy device (oad) was used for a treatment of a lesion in the mid lad.Following treatment, plaque shift was observed, and the patient complained of chest pain.The first diagonal vessel was occluded and exhibited timi 2 flow.A stent was placed, and flow returned to timi 3.There was 0% stenosis remaining.
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