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 determined the reported malposition of device (stent) appears to be related to the operational context of the procedure.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 to treat a lesion located in the superior mesenteric artery.The 7x29mm otw omni elite stent was advanced to the lesion, but during deployment, the stent jumped distally and only partially covered the lesion.Another omnilink stent was implanted to fully cover the lesion.There was no adverse patient effect or a clinically significant delay in procedure.
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