The device was not returned for 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 similar incidents from this lot.It is possible that during inflation interaction with the heavily tortuous, moderately calcified and 85% stenosed anatomy resulted in the reported difficulties; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.The treatment appears to be related to the operational context of the procedure as the physician implanted a same size xience xpedition over the dislodged xience xpedition stent to fully appose it to the vessel wall.An additional stent was used to cover part of the target lesion that was left uncovered.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was to treat a heavily tortuous, moderately calcified mid left anterior descending artery that was 85% stenosed.When a 2.5x48mm xience xpedition stent was advanced to the lesion and inflated, it then dislodged only partially covering the target lesion and not fully apposed to the vessel wall.The physician then implanted a same size xience xpedition over the dislodged xience xpedition stent to fully appose it to the vessel wall.An additional stent was used to cover the part of the target lesion that was left uncovered.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
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