During a review of the fda maude adverse event database, in a report submitted to the fda by gore (2017233-2020-00031), it was noted that an atrium tunneler was used in a procedure.The patient underwent an axillary/bifemoral artery bypass.A re-intervention took place using a gore propaten vascular graft.During the re-intervention there was bleeding noted mid-graft after tunneling with an atrium tunneler.This required the use of pledgets for patching.Mild traction was placed on the graft during the procedure and this resulted in the graft fracturing and separating from the axillary end.A 6 mm atrium tunneler was passed through the graft but it perforated the graft at the groin end.The entire graft was explanted.There are no other details regarding this event.Key information to make an assessment of the failure mode is not available.Key information would be the diameter of the gore propaten vascular graft that was in place.How long the graft had been in place and the reason for the re-intervention of the gore graft.Other information not provided was the lot number of the tunneler used in this procedure.The tunneler system was not designed to tunnel inside of a graft.The tunneler system per the indications for use states the following: "the vascular graft tunneler instrumentation is indicated for use as a device to create a subcutaneous tunnel for placement of a vascular prosthesis or autogenous graft for peripheral and extra-anatomic bypass procedures, and for vascular access." in this regard tunneling through a graft that has been placed would be and is considered misuse/user error of the device.It is unknown why the physician decided to thread a tunneler into a previously placed graft.H3 other text: not available for return.
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