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 dissection is listed in the xience xpedition, everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, 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 the procedure was performed to treat a de novo lesion in the moderately calcified, 100% stenosed mid left anterior descending coronary artery.The patient presented with chest pain, and pre-dilatation with an unspecified semi-compliant balloon was performed.A 3x33mm xience xpedition stent delivery system (sds) was advanced, and the stent was deployed.A distal dissection was noted, so an unspecified xience xpedition stent was used to cover the dissection and successfully complete the procedure.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
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