It was reported that in 2017 a xience alpine stent was successfully implanted in the proximal left anterior descending (plad) artery.On (b)(6) 2023, the patient presented with in-stent restenosis (isr) of the implanted alpine stent and new stenosis in the left main (lm) to ostial lad.The procedure was to treat the moderately calcified, moderately tortuous lesion in the ostial lad to lm.While advancing a 3.5x33mm xience sierra drug eluting stent (des) to the lesion, resistance was noted, so a non-abbott guide catheter (gc) extension was added to assist advancement of the des, which was then successfully advanced to the lesion.After removal of the gc extension and during final positioning of the stent, the stent caught on the restenosed alpine stent, and dislodged from the balloon.The delivery system balloon was used to open the proximal 1/3 part of the stent.Then two non-abbott balloon dilatation catheters (2.0x15mm, 3.0x15mm) were used to further expand the dislodged stent.A 3.5x28mm xience sierra des was then implanted from the lm to the ostial lad overlapping the dislodged 3.5x33mm xience sierra des to complete the procedure.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
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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/complaints from this lot.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.Additionally, the dislodged stent was implanted in the target vessel using additional stents.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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