The additional xience prime device referenced is being filed under a separate medwatch report number.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 / 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.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.
|
It was reported that the procedure was performed to treat a de novo lesion in the moderately calcified, moderately tortuous, right coronary artery.A 3x33mm xience prime stent delivery system (sds) was advanced, and the stent was deployed.A distal dissection was noted, so a 2.5x18mm xience prime stent was used to cover the dissection.However, another dissection was noted, so a 2.5x12mm xience prime stent was used to cover the dissection and successfully complete the procedure.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
|