It was reported that on (b)(6) 2021, the procedure was to treat a 90% stenosed lesion in the left external iliac artery.Access was gained via right iliac artery and a 7x19mm omni elite vascular balloon-expandable stent system (bes) was advanced through the 6f sheath with resistance.The stent became dislodged from the catheter into the right iliac.Several attempts were made to capture the stent with a 4mm snare but were unsuccessful.The patient was taken to surgery, where it was noted that there was a dissection and an av fistula as well.The surgical physician made a small incision, removed the stent in pieces from subcutaneous tissue and repaired the dissection in the artery.The av fistula did not require treatment and repaired itself.The patient was discharged to home on (b)(6) 2022.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
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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 identified no other incidents.The reported patient effects of dissection and fistula are listed in the omnilink elite® vascular balloon-expandable stent system, electronic instructions for use (eifu) as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported difficulties.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatments appear 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.Na.
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