A diamondback 360 peripheral orbital atherectomy device (oad) was used to treat 99% stenosed, 360-degree, calcified lesion in the right mid superficial femoral artery (sfa) via right femoral access.A non-csi/non-abbott drug-coated balloon and non-csi/non-abbott percutaneous transluminal angioplasty (pta) dilatation catheter were used to complete the procedure.The patient was discharged home the next day with no complications.Following the procedure, a core lab angiographic image review identified a type-c dissection.During a thirty-day follow-up visit in clinic the patient was stable and it was noted no adverse events occurred since the previous visit.
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H6 investigation conclusion code 22: the diamondback 360® peripheral orbital atherectomy system instructions for use user manual states that vascular dissection is a potential adverse event that may occur and/or require intervention with use of the system.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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