(b)(4).Evaluation summary: a visual, dimensional and functional inspection was performed on the returned device.The deployment difficulty and difficulty with the thumbslide were not able to be confirmed as the stent had already been deployed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar incidents.The investigation was unable to determine a cause for the reported deployment difficulty and difficulty advancing the thumbslide.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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