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.
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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 those patients treated with a web-21, five patients developed aneurysm remnants and two additional patients required aneurysm retreatments.This is report 3 of 5.(ref.Mfr.Reports #: 2032493-2021-00455, 2032493-2021-00456, 2032493-2021-00458, and 2032493-2021-00460).
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