Investigation conclusion: csi contacted the corresponding author of the article and requested model numbers and lot numbers, but neither were available.Csi also requested information regarding possible return of any of the devices used during cases with dissections, but the devices had already been discarded.The physician also stated the events were not reported to csi prior to publication of the article because, "we do not consider this as usae to report." 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.The device history record for the reported oad could not be reviewed, as the lot number was not provided.If the lot number is provided, a dhr review will be performed.Known inherent risk of device: the diamondback 360® peripheral orbital atherectomy system instructions for use manual states that dissection is a potential adverse event that may occur with use of the system.Date received by manufacturer - due to an inadvertent delay in notification of the events within the article to postmarket surveillance, the mdr was not sent within 30 days of a csi employee becoming aware.Additional training was provided regarding csi's procedures for reporting complaints to postmarket surveillance.Shammas, n.W., shammas, w.J., jones-miller, s., torey, j.T., armstrong, e.J., radaideh, q., & shammas, g.A.(2020, may 18).Optimal vessel sizing and understanding dissections in infrapopliteal interventions: data from the idissection below the knee study.Journal of endovascular therapy, 27(4), 575-580.Doi:https://doi.Org/10.1177/1526602820924815.Csi id: (b)(4).
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Shammas et.Al.2020 - a literature article was published in may 2020 which indicated the following: during procedures in which csi peripheral orbital atherectomy devices (oads) were used, dissections occurred.Specifically, the article states there were, "12 dissections after oa (8 intima, 1 media, 3 adventitia), and 11 dissections following oa+pta (7 intima, 1 media, 3 adventitia; p=0.425 vs pta)." the article also states, "bailout stenting (all due to angiographic dissections greater than or equal to c) was necessary in.None of the oa+pta group.".
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