It was reported that the procedure was to treat a heavily calcified and heavily tortuous vessel in the right coronary artery (rca).The proximal rca had an unspecified stent implanted without issues.The 2.25x18mm xience skypoint stent delivery system (sds) was being advanced to treat the distal rca, however, the stent got caught with the previously implanted unspecified stent damaging it and failed to cross the lesion.The xience skypoint stent then dislodged from the balloon and remained embedded in the artery.The procedure was discontinued.There was no adverse patient sequela and there were no clinically significant delay in the procedure.No additional information was provided.
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(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 did not indicate a lot specific quality issue.It was reported that the xience skypoint was attempted to be placed distally through a previously implanted stent.It should be noted that the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) states: when treating multiple lesions within the same vessel, stent the distal lesion prior to stenting the proximal lesion.Stenting in this order obliviates the need to cross the proximal stent during placement of the distal stent and reduces the chance of damaging or dislodging the proximal stent.The investigation determined the reported difficulties and device embedded in tissue or plaque appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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