It was reported that after removal from the dispenser coil and during removal of the protective sheath from the xience sierra stent delivery system, with no resistance reported, the stent became stretched and dislodged from the balloon.The device was not used.There was no clinically significant delay in procedure.There was no additional information provided regarding this issue.
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The device was returned for analysis.The reported material deformation and stent dislodgement were 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 other 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 include, but are not limited to, manufacturing damage, damaged during shipping, and inadvertent mishandling by user during sheath/dispenser removal.The reported material deformation appears to be related to circumstances to the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: device code 1601 -removed.
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