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 v everolimus eluting coronary stent system (eecss), instructions for use (ifu) as a known patient effect of coronary stenting procedures.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 issue with respect to manufacture, design or labeling of the device.
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It was reported that the procedure was to treat a moderately calcified, mildly tortuous, de novo, right coronary artery (rca).A 3x18mm xience v drug eluting stent (des) was advanced to the lesion and implanted; however, a distal edge dissection was noted.Another xience v stent was implanted to cover the dissection and successfully complete the procedure.There was no adverse patient sequela.No additional information was provided.
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