(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this event.The reported patient effect of intimal dissection is listed in the everolimus eluting coronary stent system, xience xpedition, instructions for use as a known patient effect.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat a 90% stenosed, eccentric lesion in the distal right coronary artery.Following pre-dilatation, a 2.5 x 12 mm xience xpedition stent was deployed; however, a proximal edge dissection was observed.A xience prime stent was successfully used to cover the dissection.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.
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