It was reported that the procedure was to treat a de novo lesion in the distal circumflex (cx) artery with mild tortuosity and moderate calcification.While advancing a 2.25x15 mm xience prime stent delivery system (sds) via direct stenting on an unspecified coronary guide wire, resistance was felt inside of the cx and upon retrieving the sds resistance was felt again.It is unknown if the resistance during advancement and withdrawal was with the guide wire or the lesion itself.Once the sds was outside of the patient anatomy, the tip of the sds was kinked and the proximal and distal portion of the stent had flared stent struts.Reportedly, the sds got damaged from stent struts of another previously implanted unspecified stent.A new same sized xience sds successfully crossed the lesion.There was no adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.
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(b)(4).Evaluation summary: the device was returned for analysis.The reported flared stent, kinked tip and difficult to position were unable to be confirmed.However, device analysis revealed a separated proximal shaft.The reported failure to advance the device and the reported difficult to remove was unable to be replicated in a testing environment as they were based on operational circumstances.Based on a visual, dimensional and functional inspection of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the information provided, a definitive cause for the reported/noted difficulties cannot be determined.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.Based on the information reviewed, there is no evidence to indicate the presence a potential quality issue with respect to manufacture, design or labeling.(b)(4).
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