H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for user manual states that hypotension is a potential adverse event that may occur and/or require intervention with use of the system.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.(b)(4).
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During a high-risk treatment of a 99% stenosed, heavily calcified mid left anterior descending artery (lad), a 6f extra back up (ebu) guide catheter was advanced, followed by the viperwire advance guide wire and diamondback 360 coronary orbital atherectomy device (oad).The oad was spun for five treatments on low speed.The patient then developed hemodynamic instability.The oad was removed, but imaging could not be taken as advanced cardiovascular life support (acls) steps were priority.Cardiopulmonary resuscitation (cpr) was performed several times, impella and extracorporeal membrane oxygenation (ecmo) were placed.The patient's blood flow and pulse restored.The physician's opinion, patient's anatomy attributed to the hemodynamic instability.
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