The device was not returned for evaluation.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.Based on the information provided, the reported difficulties and subsequent unexpected medical intervention appears to be due to circumstances of the procedure.The resistance during removal and stent dislodgement were likely due to interaction between the stent and introducer sheath during removal causing the stent to dislodge.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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