(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Dates 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.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the reported patient effect of angina is listed in the xience prime everolimus eluting coronary stent system instructions for use (ifu) as a known patient effect of coronary stenting procedures.Based on the information reviewed, 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, a 3.0x28mm xience prime stent was successfully implanted in the mid left anterior descending (lad) coronary artery lesion and a 3.5x28mm xience prime stent was successfully implanted in the proximal lad lesion.In (b)(6) 2015, the patient was hospitalized for unstable chest pain.Medication was provided and the event resolved without sequela.There was no additional information provided.
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