E1: the initial reporter's facility name is (b)(6).The initial reporter's address is 29 av du mal delattre de tassigny.H6: imdrf device code a0406 captures the reportable investigation finding of stent damage.H10: the advanix biliary stent and naviflex rx delivery system were received for analysis.Visual inspection revealed that the stent was damaged.No other damages were noted with the stent or the delivery system.Product analysis was unable to confirm the reported events of stent premature deployment and device or device component entrapment because these events occurred during the procedure and were not possible to replicate in the laboratory of analysis.However, the investigation concluded that the additional investigation finding of a damaged stent was most likely due to procedural factors such as lesion characteristics, the handling of the device, or the technique used by the physician (force applied).Taking all available information into consideration, the root cause of the reported clinical observation is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.
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