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 information reviewed, there is no indication of a product quality issue.The reported patient effect of intimal dissection is listed in the xience xpedition, everolimus eluting coronary stent system, instructions for use (ifu) 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 subsequent 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 of the device.
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It was reported that the procedure was performed to treat a 95% stenosed, mildly tortuous, and mildly calcified lesion in the right coronary artery.Following pre-dilatation with a 2.0x12mm mini trek balloon dilatation catheter (bdc), a 3.0x23mm xience xpedition stent was deployed at 10 atmospheres (atms).Post-dilatation was performed with a 3.0x8mm nc trek bdc at 18 atms.After the post-dilatation, a distal edge dissection was noted.A 2.75x12mm xience xpedition stent was used to successfully cover the dissection.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
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