It was reported that the procedure was performed to treat a target lesion in the mildly calcified and moderately tortuous right internal carotid artery.The xact stent delivery system was advanced and some resistance was noted, due to the patient anatomy.The device was removed without difficulty and additional dilatation was performed.During an attempt to re-insert the xact stent delivery system, it was noted that there was a gap at the tip of the device and the nose cone.The device was not used again and there was no adverse patient effect or clinically significant delay.A second xact stent delivery system was used without issue.No additional information was provided.
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Visual analysis was performed on the returned device.The reported difficulty advancing could not be confirmed as it was related to procedural circumstances.The tip damage was 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 other complaints.The investigation determined that the reported difficulty advancing and damage to the tip was likely related to anatomical conditions.Additionally, the damage to the tip and guide wire lumen likely occurred during the initially failed attempt to advance preventing further use when attempting to reinsert.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.
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