Investigation conclusion: csi contacted the corresponding author of the article and requested model numbers and lot numbers.Csi also requested information regarding possible return of any of the devices.No response was received from the corresponding author.If the devices do become available, they will be analyzed.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.Patient age: the average patient age was (b)(6) years plus or minus 7.1 years date of article is 4 may 2020; however, csi is aware that the events occurred on or before (b)(6) 2018.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.Kokkinidis, d., jawaid, o., cantu, d., martinsen, b., igyarto, z., valle, j.,.Armstrong, e.(2020, may 4).Two-year outcomes of orbital atherectomy combined with drug-coated balloon angioplasty for treatment of heavily calcified femoropopliteal lesions.Journal of endovascular therapy, 27(3), 492-501.Doi:https://doi.Org/10.1177/1526602820915244.(b)(4).
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Kokkinidis 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, eight type a and b dissections occurred, and three type c-f dissections occurred.
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