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 diamondback peripheral orbital atherectomy system instructions for use warns that a perforation 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.Csi id: (b)(4).
|
A diamondback peripheral orbital atherectomy device (oad) was selected to treat a heavily calcified, 90% stenosed lesion in the left posterior tibial artery.The vessel was 3.0 mm in diameter.During treatment, the patient inadvertently bent their knee and caused the crown to move laterally.The oad stalled and was removed from the patient, and imaging identified a vessel perforation.Balloon angioplasty and stent placement were performed to the perforation site and a blood pressure cuff was placed on the patient's leg to tamponade the perforation.The patient was stable following the procedure and the patient was reported to be doing well.Per the opinion of the physician, the patient's movement was the primary factor in the cause of the perforation event.
|