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 devices were implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural or post procedural images were not provided; therefore, the reported events cannot be confirmed.
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As reported through the article titled, "woven endobridge device shape modification can be mitigated with an appropriate oversizing strategy: a vasoct based study," at the last follow up visit (exact dates unknown), 7 patients that had been treated with the web device, were found to have "aneurysm neck remnants." the aneurysms were re-treated and no web treated aneurysms were reported to have ruptured.".
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