It was reported that the procedure was to treat a 100% stenosed lesion in the left common iliac artery with heavy calcification and heavy tortuosity.An endarterectomy was performed on the left common femoral artery and an 11fr sheath was placed.A 7x100mm absolute pro self-expanding stent (sess) was advanced to the left external iliac artery and deployed.Then, the 8x39mm omnilink stent delivery system (sds) was brought up to the left common iliac artery, the physician then decided not to deploy the omnilink stent and remove undeployed from the patient.However, during removal the omnilink stent became caught on the absolute pro stent and the stent of the omnilink came off the balloon.The delivery system of the omnilink was removed from the patient; however, the dislodge stent floated through absolute pro stent where it became entangled within the distal portion of the absolute pro.Therefore, physician removed both stents from the patient via a small incision in the endarterectomy patch with a snip tool.There was no adverse patient sequela.A 8x100 absolute pro stent in the left external iliac to complete the procedure.No additional information was provided.
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A visual inspection was performed on the returned stent implant.The reported device damaged by another device and difficult to remove could not be tested, as the stent delivery system was not returned for analysis and due to the condition of the returned stent implant.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 similar incidents from this lot.The investigation determined the reported difficulties and surgical intervention 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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