(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.Based on the case information and related record review, a conclusive cause for the reported patient effect(s) and the relationship to the product, if any, cannot be determined.However, stenosis is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.Additionally, the 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.
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It was reported that on (b)(6) 2014, a 3.25x38mm xience xpedition stent was implanted in the left anterior descending (lad), 70-80% stenosed lesion.On (b)(6) 2016, the patient was hospitalized for syncope.Per coronary angiography, one end of the stent contained hyperplasia, treated with medication.Per physician, the event was related to the device.There was no additional information provided.
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