As reported through the journal article titled "intracranial aneurysm treatment with intrasaccular flow disruption: comparison of web-21 and web 17 systems", from june 2015 to november 2019, 87 patients with 92 aneurysms were treated with web-21 (38/92, 41.3%) and web-17 (54/92, 58.7%).Of the patients treated with the web-17, three developed the following complications: patient 1: during the withdrawal of the web-17, the patient's aneurysm ruptured and was rapidly treated with bac (balloon assisted coiling).Patient 2: post treatment with a web-17, the patient was found to have an aneurysm remnant.Patient 3: post treatment with a web-17, the patient was found to have an aneurysm remnant.This is report 3 of 5.(ref.Mfr.Reports #: 2032493-2021-00455, 2032493-2021-00456, 2032493-2021-00459, and 2032493-2021-00460).
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The lot number is unknown; therefore, a device history record review could not be performed.The devices remain implanted in the patients and not available for return to the manufacturer for analysis, and procedure images were not provided; therefore, the alleged product issue could not be confirmed.The instructions for use (ifu) identifies aneurysm perforation or rupture as potential complications associated with use of the device.
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