The device was not returned for analysis.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 effects of angina and stenosis are listed in the xience alpine / proa everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent 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.
|
Patient id: (b)(6).It was reported that on (b)(6) 2020, the patient underwent a coronary stenting procedure, with implant of a 3.5 x 38 mm xience proa stent, a 3.0 x 23 mm xience proa stent and a 2.5 x 12 mm xience proa stent in the proximal left anterior descending (lad) artery.On (b)(6) 2022, the patient experienced symptoms of angina and was re-hospitalized.In-stent restenosis was noted in the mid lad, in the 3.0 x 23 mm xience proa stent.A revascularization procedure was performed and the event resolved on (b)(6) 2022.No additional information was provided.
|