It was reported that on (b)(6) 2020, a percutaneous coronary intervention (pci) was performed on the left anterior descending (lad) coronary artery, 100% stenosed lesion.While deploying the 3.0x18mm xience sierra stent, the stent deployed before the delivery system markers, and not exactly at the maker indication.There were no adverse patient effects reported and there was no clinically significant delay reported.No additional information was provided regarding this issue.
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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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported system motion.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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