(b)(4).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 treatments appear to be related to circumstances of the procedure.The reported patient effect of dissection is listed in the xience prime everolimus eluting coronary stent system instructions for use as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat an 85% stenosed, mildly tortuous, and moderately calcified de novo lesion in the distal left anterior descending artery.The patient presented with angina.Pre-dilatation was performed with a semi compliant balloon and a 3.0x18mm xience prime stent was implanted; however, post stenting showed an edge dissection.The dissection was successfully covered using another 3.0x18mm xience prime stent delivery system.There was no clinically significant delay in the procedure.No additional information was provided.
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