The following was reported to gore: on (b)(6) 2017, a gore® propaten® vascular graft was implanted in an above-knee femoro-popliteal procedure.On (b)(6) 2017, seroma was found.On (b)(6) 2017, the seroma was evacuated with needle aspiration.On (b)(6) 2018 a follow-up ct was performed.No action was taken at this time and physician decided to monitor the patient for any changes.On (b)(6), the physician reported severe seroma was observed through the length of the graft.On (b)(6) 2018, the gore® propaten® vascular graft was explanted.
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