Bai et al., 2021 a literature article was published and indicated the following: during procedures in which csi peripheral orbital atherectomy devices (oads) were used, dissections (5.0%), distal embolizations (1.6%) and perforations (0.5%) were perioperative outcomes that occurred.
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Date of publication was used in this field.However, cases described in this article took place between 2010 and 2016.The results of the investigation are inconclusive since the reported devices were not returned for analysis.Based on the information received, the cause of the reported events could not be conclusively determined.Additional information was requested for these events, however no additional information was able to be received.If new information is received, a supplemental report will be submitted.The device history record for the reported oads could not be reviewed as the lot numbers were not provided.If the lot number is provided, a dhr review will be performed.Bai h, fereydooni a, zhang y, tonnessen bh, guzman rj, chaar cio.Trends in utilization and outcomes of orbital, laser, and excisional atherectomy for lower extremity revascularization.Journal of endovascular therapy.October 2021.Doi:10.1177/15266028211050329.Csi id: (b)(4).
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