The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.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 patient-device incompatibility/difficulty deploying the stent.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 performed to treat a moderately tortuous and moderately calcified lesion in the right coronary artery.A 3.5x18mm xience skypoint stent delivery system (sds) was prepared per the instructions for use without issues.The sds was advanced and the stent was deployed without issues; however, post-deployment a waist (recoil) in the middle of the deployed stent was noted under fluoroscopy.The balloon was post-dilated and the waist seemed to go away, but once the balloon was deflated the waist was noted again.The stent was fully apposed to the vessel wall when initially deployed.The procedure was concluded as the stent deployment provided good results.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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