It was reported that a resolute onyx rx drug eluting stent was implanted in a patient approximately 48 days post expiry date.No damage was noted to the device packaging, and no issues noted when removing the device from the hoop/tray.The device was inspected and negative prep performed with no issues noted.No patient injury reported.No intervention reported.Please note that this device, resolute onyx is not marketed in the united states; however, it is similar to the united states marketed product resolute integrity.This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.
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