The device was not returned for evaluation as the stent remains implanted.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 effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of angina and vasoconstriction (coronary artery spasm) are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The additional device (3.0x23 mm xience sierra) referenced is being filed under a separate medwatch report number.
|
Patient id: (b)(6).It was reported that on (b)(6) 2020 two xience sierra stents (3.0x8, 3.0x23) were implanted in the first diagonal (d1) coronary artery.On (b)(6) 2020 the patient had chest pain.The stent was patent, but both stents were pinching the left anterior descending (lad) coronary artery.According to the physician, this was not an occlusion.Angioplasty was performed with a kissing balloon technique to the lad and d1.The patient had good results and the condition resolved the same day.No additional information was provided.
|