The device was not returned for evaluation.The reported patient effect of intimal dissection is listed in the xience prime / xience prime small vessel (sv), and xience prime long length (ll), everolimus eluting coronary stent system (eecss), instructions for use as a known patient effect of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, there is no indication of a product quality issue.A conclusive cause for the reported patient effect(s), 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 performed to treat an 80% stenosed, moderately tortuous, and moderately calcified de novo lesion in the left anterior descending artery (lad).Following pre-dilatation, a 2.75x08mm xience prime stent was deployed; however, during removal of the device a check shot revealed a dissection at the distal end.An unspecified 2.5x8mm stent was used to successfully treat the dissection.Results were very good with timi iii flow and no residual stenosis.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
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