(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of death estimated.Date of event estimated.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 death and myocardial infarction are listed in the xience xpedition, everolimus eluting coronary stent system, instructions for use 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 the patient was admitted to the hospital on (b)(6) 2014 for coronary heart disease.On (b)(6) 2014, the 3.5 x 15 mm xience xpedition stent was implanted in the proximal to mid right coronary artery (rca) to treat 90% stenosis in the proximal and 60% stenosis in the mid rca.The patient was discharged on (b)(6) 2014.In (b)(6) 2016, the patient fell down at home and later died despite emergency resuscitation efforts.A myocardial infarction was diagnosed.The physician reported that the relationship between the event and the device is not known.There was no additional information provided.
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