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 intimal dissection is listed in the xience xpedition 48, everolimus eluting coronary stent system (eecss), instructions for use (ifu) as a known patient effect of coronary stenting procedures.Based on the information reviewed, 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.The xience xpedition 48 is currently not commercially available in the us; however, it is similar to a device sold in the us.
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It was reported that the procedure was to treat a moderately calcified, heavily tortuous lesion in the left anterior descending (lad) coronary artery.After a 2.75x48mm xience xpedition drug eluting stent (des) was implanted at the lesion, and a dissection was observed proximal to the stent.Another device was implanted to treat the dissection and complete the procedure.There was no adverse patient sequela.No additional information was provided.
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