The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
Patient id: (b)(6).It was reported that on (b)(6) 2019, the patient presented with a distal left anterior descending (lad) coronary artery, 99% stenosed lesion.Pre-dilatation was performed and a 2.75x33mm xience sierra stent (1500275-33, 8082141) was implanted.Stent placement was deemed acceptable with 0% residual diameter stenosis, timi flow iii, and no complications.Post-procedure that same day, elevated troponin was observed.Another troponin was drawn with the results trended downward.Reportedly, the event was serious as prolonged hospitalization was required.There was no new myocardial infarction diagnosed, no treatment required, and there was no device malfunction.The event resolved without sequela and the patient was discharged home the following day, (b)(6) 2019.No additional information was provided regarding this issue.
|