Blocks d4 (lot number and expiration date) and h4 have been updated with the additional information received on september 29, 2023.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h10: an ultraflex esophageal distal release covered stent and delivery system were received for analysis.Visual examination of the returned device found the stent partially deployed.Functional examination was performed by holding the handle hub in the palm of one hand, grasping and retracting the finger ring with the other hand, and the stent was gradually released from the delivery system.No other problems were noted with the stent and delivery system.The reported event of stent partially deployed was confirmed.Taking all available information into consideration, the investigation concluded that the reported event of stent partial deployment was likely due to factors encountered during the procedure.It may be that lesion characteristics, how the device was handled, and/or the technique used by the physician, could have contributed to the reported event.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
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