It was reported that the procedure was to treat a de novo lesion located in the mildly tortuous, mildly calcified, 95% stenosed, mid left anterior descending artery (lad).The 3.0x23 mm xience prime stent was deployed in lad.During deployment a stent edge dissection was observed.A 3.0x15 mm xience prime stent was used to cover the dissection.No predilatation was performed prior to stenting.There was no reported clinically significant delay in the procedure.No additional information was provided.
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(b)(4).Intimal dissection is listed in the xience prime everolimus eluting coronary stent systems instructions for use (ifu) 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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