Summary device evaluation: the investigation of the returned device found only the pusher, dispenser hoop, and product pouch present upon receipt.The stent and introducer were not returned.As a component other than the stent was not returned and no documentation of the package as it was opened during the procedure was provided, this evaluation could not verify the absence of the stent within the package as described in the reported event.Furthermore, the build records indicate that the devices in this lot (210607524) passed all inspections; therefore, this device was verified to have the stent present within package at the time the device was shipped.
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