It was reported that the procedure was to treat an external iliac artery.The 9.0x29mm omnilink elite stent was advanced through a 6fr sheath; however, resistance was felt and the device became stuck.The device was able to be removed separately, but resistance was still felt with the sheath.An absolute pro was used to successfully complete the procedure with the same 6fr sheath.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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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 other incidents.The investigation was unable to determine a conclusive cause for the reported difficult to advance and difficult to remove.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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