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 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 diamondback coronary orbital atherectomy device instructions for use states that perforation and death are possible adverse events which can occur with use of the diamondback coronary orbital atherectomy device.Csi id# (b)(4).
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A diamondback coronary orbital atherectomy device (oad) was selected for treatment of a heavily calcified right coronary artery (rca).The lesion was 80% stenosed and the vessel was extremely tortuous.One short treatment on low speed was performed, and a perforation was observed.Treatment included a covered stent, pericardiocentesis, and the insertion of a ventricular assist device.The patient coded, and cpr was performed.The patient's family decided to discontinue life saving measures, and the patient expired.
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