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 intimal dissection is listed in the xience prime everolimus eluting coronary stent system (eecss), instructions for use (ifu) as a known patient effect of coronary stenting procedures.Based on the information reviewed, there is no indication of a product quality issue.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent 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 of the device.
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It was reported that the procedure was to treat a lesion in the moderately calcified, mildly tortuous, 80% stenosed, de novo left anterior descending (lad) artery.After a 3.5x28mm xience prime drug eluting stent (des) ) was implanted and post-dilated in the target lesion, a distal edge dissection was noted.Therefore, a 3.5x15mm xience prime des 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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