It was reported that during device preparation, the 3.5x38mm xience sierra drug eluting stent (des) was prepared prior to the sheath removal.During removal of the protective sheath, without resistance, the stent dislodged.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided regarding this issue.
|
A visual and dimensional inspection was performed on the returned device.The reported stent dislodgement was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported stent dislodgement; however, factors that may contribute to stent dislodgement prior to use include, but are not limited to, crimping during manufacturing, incorrect sheath sizing, negative pressure during sheath removal, forced sheath removal, mishandling during product preparation for use, or interaction with accessory devices.In this case, it is possible that inadvertent mishandling during protective sheath/stylet removal resulted in the reported stent dislodgement; however, this cannot be confirmed.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
|