Investigation conclusion code 22: the diamondback 360® peripheral orbital atherectomy system instructions for user manual states that an embolism 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.Csi id: (b)(4).
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A distal embolism of plaque was observed following two low speed, three medium speed, and four high speed treatments in a 90% stenosed, 5.5mm lesion in the distal superficial femoral artery (sfa) with a diamondback 360 peripheral orbital atherectomy device.An anticoagulant medication was administered, flow was improved, and good flow was established.Angioplasty was performed to complete the procedure.The patient was stable.Additional information received on 2/14/2024 indicated there were no procedural complications.No adverse event occurred or allegations of malfunction against the csi device.Additional information received on 3/07/2024 found the embolism was possibly related to the oad.
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