Yamamoto et.Al., 2021 - a literature article was published on 16 december 2021 and indicated the following: calcified stenosis and a heavily calcified plaque in the left anterior descending artery (lad) were revealed via coronary angiograms and computed tomography (ct) scan, respectively.Intravascular ultrasound indicated the presence of an eccentric calcified atheroma.One atherectomy treatment was performed on low speed and one on high speed advancing distally to proximally.Immediately following treatment with a diamondback 360 orbital atherectomy device (oad), the patient experienced no flow.Nitroprusside was administered, but coronary flow delay did not fully improve, and ventricular fibrillation occurred.The patient's condition was resolved with extracorporeal cardiopulmonary resuscitation and the procedure was completed with the placement of a drug eluting stent.
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Date of event: the date csi became aware of the event.(b)(4).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.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.Yamamoto, h., takaya, t., sawada, t., and kawai, h.(2021, december 16).Dark crescent sign: high-risk calcified coronary plaque detected by electrocardiogram-gated non-contrast computed tomography.Escc: european heart journal - case reports (2022) 6(1), 1-2.Doi.Org/10.1093/ehjcr/ytab519.Csi id: (b)(4).
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