The xience stent is filed under separate medwatch report number.The udi number is not known as the part and lot number were not provided.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.Based on the information provided, the reported difficulty appears to be due to circumstances of the procedure.It is likely that the reported interaction with the stent caused the difficulty while attempting to remove the catheter.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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