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.Per the physician, it was unknown what the cause of the dissection was.(b)(4).
|
The stealth peripheral orbital atherectomy device (oad) was operated in the distal anterior tibial (at) artery, and balloon angioplasty was performed.During removal of the oad, the device became stuck in the distal at.The device was eventually removed after it was activated on low speed.Balloon angioplasty was performed, and treatment to the tibioperoneal trunk and peroneal artery was performed with a second oad.A dissection was observed in the at where the first oad had become stuck in the proximal at.It was unknown when the dissection occurred, and a stent was placed to resolve it.The patient was in stable condition.
|