The device was not returned for evaluation.A review of the lot history record identified no manufacturing non-conformities 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 everolimus eluting coronary stent system (eecss), 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.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The other xience xpedition stent referenced is filed under a separate medwatch report number.
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It was reported that the procedure was to treat de novo lesions located in the right coronary artery (rca) and left anterior descending (lad) coronary arteries that were both moderately calcified and tortuous.After implantation of the 3.0x28mm xience xpedition stent in the rca, a dissection was observed.A 3.0x15mm xience xpedition stent was implanted as treatment.After implantation of the 3.5 x 23mm xience xpedition stent in the lad, a dissection was observed.A xience xpedition 3.5x15mm xience xpedition stent was implanted as treatment.There was no adverse patient sequela.The patient remained stable and was discharged.There was no additional information provided.
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