It was reported that the procedure was to treat a lesion in the right coronary artery (rca).The 3.5x33mm xience skypoint stent delivery system (sds) attempted to cross the target lesion; however, failed to cross due to the anatomy and the sds was removed and re-inserted.While attempting to cross the target lesion the guideliner and guidewire moved back and the stent became dislodged.Therefore, a snare was used to remove the dislodged stent.There was no adverse patient sequela.Another xience skypoint was used to complete the procedure.No additional information was provided.
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The device was returned for analysis.The reported stent dislodgement was confirmed.The reported failure to advance could not be replicated in a testing environment as it was related to operational context of the procedure.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 determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the difficulty anatomy resulting in the reported failure to advance.Additionally, multiple attempts were made to cross the lesion and manipulation of the device and/or interaction with other devices as the device was removed then re-advanced (against the instructions for use) resulted in the noted stent dislodgement and unexpected medical intervention.It should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged or dislodged during retraction back into the guiding catheter.In this case, it is unknown if the instruction for use (ifu) deviation related to re-insertion caused/contributed to the reported event.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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