It was reported that the procedure was to treat a lesion located in the moderately tortuous, mildly calcified, distal left descending artery.After deployment of a 2.5 x 38mm xience prime stent in the lesion, a distal edge dissection occurred.A 2.5 x12mm xience prime stent was implanted to cover the dissection successfully.There was no clinically significant delay in the procedure reported.No additional information was provided.
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(b)(4).Dissection is listed in the xience prime long length (ll), everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.Although a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined, there is no indication of a product quality deficiency with respect to manufacturing, design or labeling.
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