The device lot number was not provided; therefore, a device history record and non-conformance review could not be performed.The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be verified.The instructions for use (ifu) identifies thrombus as potential complications associated with use of the device.Bibliography: endo, hideki, et al."long-term outcomes of y-stent-assisted coil embolization using low-profile visualized intraluminal support junior (lvis jr) for intracranial bifurcation aneurysms." clinical neurology and neurosurgery 217 (2022): 107275.
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As reported through the article titled, "long-term outcomes of y-stent-assisted coil embolization using low-profile visualized intraluminal support junior (lvis jr) for intracranial bifurcation aneurysms," a study compromising of twenty-one patients (22 aneurysms) that had been treated with y-stent-assisted coiling using lvis jr.Was performed.All procedures were performed successfully; however, it was reported that with one patient, a small amount of thrombus was found in the stent during the procedure.Thus, his antithrombotic therapy was intensified using ozagrel sodium (thromboxane a2 synthase inhibitor), additional heparin, argatroban (direct thrombin inhibitor), and cilostazol.The patient did not develop any neurological symptoms after the procedure or during the follow-up period.
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