(b)(6).It was reported that the procedure was performed to treat a lesion in the proximal right coronary artery (rca).The first 3.5 x 12 mm xience sierra stent delivery system was advanced to the target lesion without issue; however, on angiography, the stent delivery system balloon appeared slightly inflated, as if the stent was slightly expanded.The device was removed without difficulty and the stent remained on the delivery system balloon.The second 3.5 x 12 mm xience sierra stent delivery system was then advanced to the target lesion.No difficulty was noted; however, this stent delivery system balloon also appeared slightly inflated, as if the stent was slightly expanded.The device was removed without difficulty and the stent remained on the delivery system balloon.The procedure continued with implantation of a 3.5 x 15 mm xience sierra stent.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
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A visual inspection was performed on the returned device.The reported defective device and material deformation was not confirmed as there was no damage noted to the stent implant and the stent implant was stationary on the tightly folded balloon, between the markers.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 issues, as they could not be confirmed during return analysis testing.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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