A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was implanted in the patient.Additionally, procedural or post-procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies thrombosis as a potential complication associated with use of the device.
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As reported through the article titled, "clinical and angiographic outcomes of stent-assisted coiling of paraclinoid aneurysms: comparison of lvis ap21-1746nd neuroform stents," 12 patients that were treated for aneurysms with the implantation of the lvis stent (exact dates unknown) were reported to have developed stent-related thrombosis (symptomatic in 2 patients, non-symptomatic in 10 patients).
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