A non-gore sponsored clinical trial/study is being done at (b)(6) hospital to investigate the efficiency, mechanism of action and safety of creating an av fistula for the treatment of critical limb ischemia, first-in man clinical investigation study.After enrollment into the clinical study on (b)(6) 2016, the patient was implanted with three gore® viabahn® endoprostheses on (b)(6) 2016.The implant procedure was performed in the lower right limb in the posterior tibial vein.On (b)(6) 2016, the patient was confirmed with the poor healing-medial malleolus wound.The viabahn® devices were exposed, with surrounding purulent discharge.The patient then underwent a right lower limb wound debridement and the three infected viabahn® devices were explanted on (b)(6) 2016.As reported by the user facility, the poor healing and the infection were not considered to be caused by the viabahn® devices but rather by the initial surgery to cut down for venous access that was done prior to implant procedure.The patient recovered well and was discharged on (b)(6) 2016.Patient is reported to be doing well at this time.
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