It was reported that during a coronary orbital atherectomy procedure starting at 10:59pm on (b)(6) 2015, the patient became bradycardic, went into ventricular tachycardia (vtac) and expired 12:07am (b)(6) 2015.The target lesion was located in the left anterior descending (lad) artery.The physician crossed the lesion with a crossing wire and exchanged it out for a csi coronary viperwire guidewire.A csi orbital atherectomy device (oad) was loaded onto the guidewire and the physician completed the first run at low speed for 27 seconds.The patients blood pressure dropped slightly so adenosine was administered to resolve it.During the second run at low speed, the patient's pressure again dropped.The patient then became bradycardic and felt dizzy.Dopamine and epinephrine were administered, but the patient then went into vtac.Additional epinephrine was administered and chest compressions were performed to stabilize the patient.The physician then performed a third run at high speed using the csi oad, but again the patient's pressure dropped and went into vtac.Atropine and epinephrine were administered and chest compressions were performed, but the patient expired.Three requests for additional information have been made, but none has yet been received.
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The device was discarded by the facility; therefore, an analysis of the actual complaint device is not possible.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.(b)(4).Discarded by facility.
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