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.The stealth gen2 peripheral orbital atherectomy system instructions for use states that a distal embolization is a potential adverse event that may occur and/or require intervention as a result of the use of this device.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 (b)(4).
|
Treatment with a stealth peripheral orbital atherectomy device was performed on low, medium and high speed to a 7mm, 80% stenosed and heavily calcified superficial femoral lesion.An ultrasound revealed that an emboli of calcium had migrated to the distal dorsalis pedis (dp) artery.Vasodilators were administered and additional balloon angioplasty to the tibial and dp arteries were performed.The procedure was completed and the patient experienced no additional pain or discomfort.
|