The diamondback 360® coronary orbital atherectomy system instructions for use manual states that hypotension, vessel perforation, and arrhythmia are potential adverse events that may occur and/or require intervention.In the opinion of the physician, the cause of the events was the fragility of the patent's vasculature.However, 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.Csi id: (b)(4).
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The patient became hypotensive following the first proximal to distal treatment on low speed with a diamondback coronary orbital atherectomy device (oad) in the mid circumflex artery (cx).The oad was removed from the patient.Imaging was performed, and a perforation was observed in the distal segment of the lesion.The patient experienced ventricular tachycardia, cardiopulmonary resuscitation was started, and acls medications were administered to stabilize the patient.Pericardiocentesis was performed, and an impella device was placed following angioplasty.The patient was stable following the procedure.
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