It was reported that on (b)(6) 2018, the patient underwent a coronary stenting procedure.At the end of the procedure, a filling defect was noted in the mid left anterior descending artery which appeared to be thrombus.Aspiration thrombectomy was performed and the event resolved the day of onset.One day post procedure, the patient experienced a troponin rise.No treatment was provided and the study physician deemed the enzyme elevation as unrelated to the implanted stent.The event resolved on (b)(6) 2018.No additional information was provided.
|
(b)(4).Correction: mfr info.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.The reported patient effect of thrombosis is listed in the xience alpine, everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|