A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported failure to advance could not be tested as it was based on operational circumstances.The reported difficult to remove could not be tested due to the condition of the returned device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It was reported that the procedure was to treat a heavily calcified left superior mesenteric artery.It should be noted that the omnilink elite instructions for use, states: the omnilink elite stent system is indicated for the treatment of atherosclerotic iliac artery lesions with reference vessel diameters of = 5.0 mm and = 11.0 mm, and lesion lengths up to 50 mm.It is unknown if the ifu deviations directly caused or contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure, as it is likely the omnilink elite interacted with the heavily calcified anatomy during advancement of the device, causing the reported failure to advance.Further interaction with the challenging anatomy in addition to the tip of the guide catheter during retraction of the device likely contributed to the reported difficult to remove, ultimately causing the reported stent dislodgement and noted material deformation (stretched, mangled, and flared).The dislodged stent was retrieved with forceps from the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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