(b)(4).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 incidents from this lot.It should be noted the device was not prepped outside of the anatomy as indicated in the xience alpine instructions for use.It should be noted that the xience alpine everolimus eluting coronary stent system instruction for use (ifu) lists device preparation to be performed prior to insertion into the anatomy.In this case, it is unknown if the ifu deviation related to incorrect stent preparation may have contributed to the reported event.The intent with prepping outside of the anatomy prior to use is to identify any defects or leaks and prevent issues during the procedure.In this case, it is unknown if the instruction for use deviation may have prevented the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.The investigation was unable to determine a conclusive cause for the reported material rupture; however, factors that may contribute to material ruptures include, but are not limited to, material damage, interactions with other devices or interaction with lesion calcification and tortuosity.The reported migration and treatment appear to be related to operational context as it is likely the material rupture below rated burst pressure caused the stent to be under deployed which likely caused the reported stent migration and subsequent treatment.Based on the information reviewed, 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 performed to treat a lesion in the mildly calcified, mildly tortuous left circumflex coronary artery.A 2x28mm xience alpine stent delivery system (sds) was not prepped outside the anatomy prior to use.The sds was advanced without resistance, and the balloon ruptured during deployment at 10 atmospheres.During removal of the sds, the stent migrated to the left main artery, so it was only partially in the target lesion.Multiple unspecified balloons and an unspecified stent were used to dilate the migrated stent and successfully complete the procedure.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
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