The device history record for the reported oad could not be reviewed as the lot number was not provided.If the lot number is provided, a dhr review will be performed.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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The crown became stuck and the diamondback 360 coronary orbital atherectomy device (oad) stalled in the left main coronary artery (lm), which resulted in hypotension and severe ischemia.The device was forcefully extracted, and wire position was lost.The physician then advanced a low-profile balloon, followed by intravascular lithotripsy (ivl) and stent placement.The patient was stabilized with vasopressors and fluids.
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