Terumo (b)(4) reported that a patient who had a gelsoft bifurcate implanted in 2007 had reported pain within the inguinal region (groin area).Investigation by the site confirmed that the graft had ruptured and blood leakage occurred (leakage location is unknown).The patient underwent an elective procedure where the ruptured area of the graft was anastomosed (sutured).The procedure was successful, and the patient is doing well.No device identification information or photos of the issue are available.
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