It was reported that during an intervention with the xience skypoint stent system, during stent deployment, the stent moved more proximally in the vessel than intended.However, it did not move outside the target lesion.There was no reported adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
|
The unique device identifier (udi) is unknown because the part number and lot number were not provided.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the part and lot number were not provided.The investigation was unable to determine a conclusive cause for the reported malposition of device.However, factors that may contribute to malposition of device include, but are not limited to, incorrect stent size for lesion, challenging anatomy, user technique, or interaction with accessory devices.In this case, it is possible the stent delivery system (sds) interacted with the balloon during deployment, as stent movement was noted after inflation, causing the reported malposition of device; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
|