(b)(4).An ultraflex esophageal ng distal release uncovered stent and delivery system were received for analysis.The stent was returned fully deployed and the position of the stent was at the proximal section of the delivery handle.Visual examination of the returned device found the deployment suture was inside the stent.The stent was partially unraveled, some stent wires were broken, and the shaft was crossing the stent.A destructive inspection was performed and the finger ring of the deployment suture was cut in order to remove the cord from the stent.The stent deployment suture was found in good condition.No other issues were noted to the stent and delivery system.The reported event of stent deployment suture knotted and stent partially deployed were not confirmed.The stent was received fully deployed and the stent deployment suture was not knotted.The damages noted to the returned stent were most likely due to procedural factors encountered during the procedure.Handling and manipulation of the device could lead to the shaft crossing the stent and difficulty positioning the stent resulting in broken stent wires and stent unraveled.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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