The device was not returned for analysis.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 did not indicate a lot specific quality issue.In this case, it is likely that the device interacted with the mildly calcified, heavily tortuous, heavily stenosed lesion and previously implanted stents during advancement, as resistance was noted, causing the reported failure to advance.Interaction with the 6f (french) guide catheter, as strong resistance was noted, likely contributed to the reported difficult to advance/position due to the device not being properly supported or coaxially aligned during advancement.Further interaction with the previously implanted stents during retraction of the device likely contributed to the reported difficult to remove, ultimately causing the reported stent dislodgement.The investigation determined the reported difficulties and foreign body in patient, surgical intervention, in addition to unexpected medical intervention (additional therapy/non-surgical treatment) appear to be related to circumstances 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 heavily stenosed lesion in the left common iliac artery with mild calcification and heavy tortuosity.There were two previously implanted stents in the external iliac.The 9x29mm otw omni elite balloon-expandable stent (bes) was advanced and strong resistance was noted with the 6f sheath.The bes and the sheath met strong resistance advancing in the anatomy, and the bes failed to cross to the target lesion.The bes was removed from the sheath to determine the cause of the resistance; however, during removal the bes got stuck with the edge of a previously implanted stent, the omni elite stent separated off the balloon into the left common iliac.Attempts were made for 2 hours to snare the stent, but this was unsuccessful and the patient was sent to surgery.The stent was unable to be removed with surgery; therefore, the patient was hospitalized for observation.The stent was later embedded in the arterial wall with a covered stent.There was no adverse patient sequela.No additional information was provided.
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