Block e1: the initial reporter's phone number is (b)(6).Block h6: imdrf device code a15 captures the reportable investigation results of stent partially deployed.Block h10: an ultraflex esophageal proximal covered stent and delivery system were received for analysis.The stent was received partially deployed.Visual inspection found the shaft kinked.During functional inspection, it was not possible to deploy the stent by pulling the finger ring as the shaft bowed due to the kink on the shaft; however, the stent was able to be deployed by pulling the black deployment suture distal to the delivery handle.The reported event of stent failure to deploy was confirmed because the stent was received partially deployed.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied), could have contributed to the observed problem of shaft kinked which resulted in the stent being unable to fully deploy during the procedure.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.
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