(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.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 effects of angina and stenosis are listed in the xience prime everolimus eluting coronary stent system (eecss), 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.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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It was reported that on (b)(6) 2013 the 3.0x18 mm xience prime stent was implanted in the proximal left anterior descending coronary artery (plad).The patient had unstable angina with diaphoresis, fatigue, and burning pain behind the sternum on (b)(6) 2018.The patient was admitted to the hospital for one day on (b)(6) 2018 and discharged on (b)(6) 2018.Coronary angiogram found 30% stenosis in the plad, but no treatment was performed.The condition resolved upon discharge.No additional information was provided.
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