It was reported that the procedure was to treat a lesion located in the distal right coronary artery that was mildly calcified, mildly tortuous and 90% stenosed.During attempted deployment of the 3.0 x48 mm xience xpedition 48 stent, the balloon failed to inflate to deploy the stent.Trouble shooting was attempted, including changing the contrast to saline percentage, but unsuccessful, so the device was attempted to be removed.During removal, the balloon was thought to be inflated to 6 atmospheres, but because the thought was that it could not be inflated, it was unintentionally deployed in the middle part of the lesion.Two additional non-abbott stents were deployed, one distal and one proximal to the xience xpedition stent.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.
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The device was returned for analysis.The reported inflation issues could not be confirmed due to the condition of the device as it was received with a longitudinal tear on the outer member.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.It was reported xience xpedition stent delivery system (sds) was unable to inflate to 12 atms; therefore, contrast mix was changed from 1:1 to 100%.It should be noted that the xience xpedition everolimus eluting coronary stent system instruction for use (ifu) lists 60% contrast diluted 1:1 with normal saline as the required contrast mix.It is unknown if the ifu deviation may have contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported inflation problem.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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