The device was not returned to abbott vascular for analysis.A query of the complaint handling system database for the reported lot revealed no other similar incidents and/or complaints reported for stent dislodgement.Return of the stent delivery system may have further aided the analysis.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 other incidents reported from this lot.Factors that can contribute to stent dislodgement include, but not limited to; improper or inadequate crimping at the time of manufacture, incorrect sheath sizing, positive pressure during preparation, forced sheath removal, handling of the stent during preparation, and interaction with the lesion, accessory devices, and/or previously implanted stents.To ensure this is not the result of a manufacturing issue, all sds are inspected for proper stent placement, stent damage and crimped stent outer diameter.The investigation was unable to determine a conclusive cause for the reported stent movement.There is no indication of a product quality issue with respect to the design, and manufacture of the device.Na.
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It was reported that during preparation, the 8x29mm omnilink elite vascular balloon-expandable stent system (bes) was removed from the packaging and after removal of the protective sheath, the end of the stent was loose on the balloon.The bes was discarded, and another device was used to successfully complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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