A diamondback 360 coronary orbital atherectomy device (oad) was used to treat a lesion in the left circumflex artery.During the first treatment, the oad crown jumped 5 to 7mm through the lesion after releasing tension with the device throw before turning on the oad.The physician stopped the treatment to observe the angiographic imaging.A perforation was observed in the left circumfelx artery.The oad was removed, and balloon angioplasty was performed.After balloon angioplasty, the physician attempted to place a covered stent, however, this was unsuccessful, and the procedure was aborted with only balloon angioplasty being performed.The patient was in stable condition.
|
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).
|