Exemption number e2019001.The device was not returned for evaluation.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 revealed no other similar incidents.Based on the information provided, a definitive cause for the difficulty could not be determined.It may be possible that the introducer sheath was too close to the stent during deployment resulting in the stent partially deploying into the sheath; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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