The following was reported to gore: the patient underwent vascular graft replacement of the popliteal artery on (b)(6) 2015.The patient fell, twisting his previously treated leg on (b)(6) 2015.A circumferential tear at the distal end of the graft along the suture line was noted.On (b)(6) 2015, the torn portion of the graft was explanted and replaced with a new gore® propaten® vascular graft.The patient is doing well.
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Summary of returned device evaluation: the returned device was subjected to an acid digestion process to remove biologic debris.Following digestion, the device was examined for material disruptions with the aid of a stereomicroscope.The device was then prepared for scanning electron microscopy (sem) using platinum sputter coating and examined.Disruptions identified were not associated with handling or manufacturing process at wl gore and associates.The disruptions are consistent with a surgical procedure.Marks consistent with a surgical instrument are present on the abluminal surface.Pull through of the anastomotic sutures and an area of graft rupture were identified.The suture pull tracks and their associated angles, and section of graft rupture indicate that the anastomotic site was subjected to sudden tension in multiple directions.The instructions for use state: caution the patient against extreme or abrupt movements of the arm, shoulder, or legs during a convalescent period of six-to-eight weeks to allow for adequate healing.Routine activities such as reaching out in front, raising arms above the shoulder level, throwing, pulling, striding, or twisting should be avoided.
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