It was reported that the procedure was to treat a de novo lesion located in the mid left anterior descending coronary artery that was both mildly calcified and tortuous and 90% stenosed.After the lesion was predilated, the 2.5x18mm xience skypoint stent system was advanced to the lesion and during stent deployment, a leak was noted, so high-speed inflation was performed, successfully implanting the stent.After removal of the stent delivery system, a pinhole rupture was noted on the tip of the device.Post-dilatation was performed with an nc balloon and intravascular ultrasound (ivus) confirmed the stent was well apposed to the vessel wall.There was no adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.
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A visual and functional inspection was performed on the returned device.The reported leak / splash and material rupture were confirmed.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 was unable to determine a conclusive cause for the reported difficulties.Factors that may contribute to a leak include, but are not limited to, damage to the inflation lumen, loose connection with the indeflator, and/or damage to the balloon.Factors that may contribute to a material rupture include, but are not limited to, material damage, inflation technique, interactions with other devices, lesion calcification and tortuosity, and/or insufficient preparation prior to use.In this case, it is possible that the stent delivery system (sds) interacted with an accessory device and/or the mildly calcified, mildly tortuous, and 90% stenosed lesion during advancement, contributing to the reported material rupture and subsequent leak; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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