(b)(4).The additional 2.25 x 15 xience sierra device is being filed under a separate medwatch report.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 similar incidents from this lot.The investigation determined the reported difficulties 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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It was reported that the procedure was to treat a moderately tortuous right coronary artery.A 3.25 x 28 mm xience sierra stent was implanted along with 3 other unspecified xience sierra stents without any device issues.As a gap was noted between 2 stents, a 2.25 x 15 mm xience sierra stent was advanced to the lesion; however, the stent became caught with the 3.25 x 28 mm sierra stent.It was noted under angiography that the 3.25 x 28 mm sierra stent was not damaged.The 2.25 x 15 mm sierra stent delivery system (sds) was then moved back and forth to remove the stent, and it dislodged.Therefore, an unspecified trek and a 1.5 x 12 mm mini trek balloon catheter were used to crush the stent to the 3.25 x 28 mm stent.Post-dilatation was then performed with a 3.5 x 15 mm nc trek balloon catheter to successfully complete the procedure.No additional information was provided.
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