Csi contacted (b)(4) (distributor) in the geography where these events occurred in order to attempt to obtain the complaint devices and event informaton, and additional information has not yet been received.If additional information is received, a supplemental report will be submitted.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.Yutaka tanaka, shohei yokota, takahiro hayashi, hirokazu miyashita, hiroaki yokoyama, kazuki tobita, koki shishido, shingo mizuno, futoshi yamanaka, saeko takahashi, and shigeru saito.Procedural and clinical outcomes with the diamondback 360 orbital atherectomy system: a classic crown with glideassist and viperwire advance flextip j am coll cardiol.2020 mar, 75 (11_supplement_1) 1237.Serious injury information received in this literature article is reported in mdr 3004742232-2021-00130.Csi id: (b)(4).
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Tanaka et al.2020 - a literature article was published 24 march 2020 and indicated that cardiac deaths was 2.1%.Per the physician, the csi devices and wires did not cause the myocardial infarction, target vessel revascularization or cardiac deaths but may have contributed.
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