(b)(4).Udi#: in the absence of a reported part number, the udi cannot be calculated.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the part and lot numbers were not reported.The investigation was unable to determine a conclusive cause for the reported stent migration.It may be possible that the stent was undersized for the vessel; however, this could not be confirmed.The additional surgical procedure to remove the stent was due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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