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 investigation determined the reported difficulties 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.
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It was reported that the procedure was to treat the right subclavian artery with moderate calcification, moderate tortuosity and 70% stenosis.During positioning of the 8x19 mm omnilink elite stent delivery system (sds), the device reached the lesion but became stuck in the artery.All devices were removed as a single unit.The sds was replaced with a new 8x29 mm omnilink elite sds which was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
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