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(s) of dissection is listed in the xience xpedition everolimus eluting coronary stent system instructions for use as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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 lesion with mild calcification, mild tortuosity, and 95% stenosis in the left anterior descending artery.The lesion was pre-dilated with a 3 x 12 mm trek balloon.Then, a 3.5 x 48 mm xience xpedition stent was deployed at 10 atmospheres.Post-dilatation was performed with a 3.5 x 15 mm nc trek balloon at 18 atmospheres.However, after post-dilatation, an edge dissection was noted at the distal edge of the stent.A 3 x 12 mm xience prime was deployed to treat 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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