A sapphire balloon was unable to cross over and dilate a 99% occluded, heavily calcified, tortuous lesion in the mid right coronary artery (rca).Dilation attempts were made with a 1.0mm sapphire balloon and a 2.0mm sapphire balloon.Both balloons ruptured.Dissections were observed proximal to the lesion.The physician decided to proceed with the atherectomy procedure and used a guideliner to protect the dissection area.A diamondback 360 coronary orbital atherectomy device (oad) was used for three low-speed treatments.The oad crown jumped, and a perforation of the mid rca was observed.Stents were placed and prolonged balloon tamponade were performed.A small pericardial effusion was noted as well, and a pericardiocentesis was performed removing 40cc of fluid.The patient remained stable and was monitored overnight.The following day, an angiogram was performed revealing the formation of a large pseudoaneurysm at the site of the perforation.The patient was transferred to another facility for placement of a covered stent; however, the facility was unable to wire the vessel which led to the patient undergoing bypass surgery.In the opinion of the physician, using the oad in the presence of a dissection likely resulted in the perforation.The patient was in stable condition.
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Related regulatory report: (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.Csi id: (b)(4).
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