(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot did not reveal a lot specific product issue.The rx herculink elite renal and biliary stent system instructions for use state that the system is indicated for use in patients with atherosclerotic disease of the renal arteries or restenotic atherosclerotic lesion located within 10 mm of the renal ostium.It could not be determined if the off-label use contributed to the reported difficulties.It is likely that dislodgment occurred due to interaction with the heavily calcified anatomy.The investigation determined the reported difficulties appear to be related to operational context of the procedure and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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