Optical coherence tomography (oct) imaging was performed, confirming a slightly tortuous, calcified lesion in the left anterior descending (lad) artery.One treatment was performed on low speed using the diamondback 360 coronary orbital atherectomy device (oad).Oct imaging revealed healthy tissue had been damaged.No hemorrhage was observed, and a second treatment was performed on low speed.Six treatments were then performed on high speed.Oct imaging revealed the lesion had been sufficiently reduced.A cutting balloon was placed, followed by stent placement and balloon angioplasty.The physician realized the blood vessel had ruptured and the patient's condition worsened.A perfusion balloon was placed but was unsuccessful in achieving hemostasis.Percutaneous cardiopulmonary support (pcps) and ventricular support were used, and a covered stent was placed.The patient was moved to the intensive care unit (icu).The patient's condition worsened due to the hemorrhage.Hemostasis was achieved via surgical procedure.Four days following the procedure, the patient's condition improved became stable.The pcps and ventricular support device were removed.
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The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.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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