It was reported that the procedure was to treat a moderately calcified, moderately tortuous, 80% stenosed lesion in the subclavian artery.A 9x19mm omni elite 35 balloon-expandable stent system (bess) was advanced through a 6 french (f) guiding catheter (gc) to the target lesion.During withdrawing of the gc before the stent was deployed, resistance was met between the gc and the stent, and the stent was pulled back together with the gc causing the stent strut to become flared and dislodged from the system balloon.The dislodged stent migrated in the subclavian artery.The flared stent struts adhered to the intimal layer of the vessel.The stent was removed by cutting the vessel.Another same size omni elite 35 bess was used to successfully complete the procedure.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.
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A visual inspection was performed on the returned device.The reported material deformation and stent dislodgement were confirmed.The reported difficult to remove could not be tested due to the condition of the returned device.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 investigation determined the reported difficulties in addition to removal of foreign body and surgical intervention (surgical procedure) 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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