(b)(4).No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The device was not returned.Therefore, direct product analysis was not possible.No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The device was not returned.Therefore, direct product analysis was not possible.
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It was reported to gore that in 2016 (date unknown), a patient was implanted with a gore® acuseal vascular graft in the forearm for arteriovenous access.The graft was anastomosed as a loop graft.In (b)(6) 2017 (date not specified), the patient presented with tissue and graft infection, as well as graft exposure.The gore® acuseal vascular graft was explanted and a gore® propaten® vascular graft was implanted in the same location.It was also reported the patient has thin subcutaneous tissue.The patient tolerated the procedure.
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