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 system 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 to treat a de novo lesion located in the right coronary artery (rca) that was moderately calcified and 85% stenosed.After lesion pre-dilatation, the xience xpedition 3.0x28mm drug eluting stent (des) was implanted; however, a distal end dissection was noted.A 3.0x8.0mm des was implanted as treatment, resulting in good flow.There was no adverse sequela.No additional information was provided.
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