(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 effect of angina and stenosis are listed in the xience xpedition, everolimus eluting coronary stent system, 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.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) 2015, a 3.5x28mm xience xpedition was successfully implanted in the proximal left anterior descending (lad), 95% stenosed lesion.On (b)(6) 2018, the patient was hospitalized with unstable angina and diaphoresis.The 3.5x28mm xience xpedition stent had distal stenosis (90%).As treatment, a non-abbott stent was implanted.The patient was discharged home on (b)(6) 2018.No additional information was provided regarding this issue.
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