The patient underwent an initial operation on (b)(6) 2016 for a recurrent hernia, and the device was implanted.On (b)(6) 2016, the patient got a "burst" stomach due to relapsing cough.An immediate re-operation was necessary.During the reoperation, the device was found to be ripped in the area of the fixation seams.It was also found to have defects in the net area where no seam fixation was made.The device was explanted.
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(b)(4).A visual examination of the returned device revealed the following: the sample was not returned in its original packaging but in a container with saline solution; the mesh had been cut; there were holes and a tear at different locations of the mesh (not only at the fixation points); and the tears were not in the direction of the fibers.It was determined, based on the physical evaluation of the device, that a combination of potential residual infection of the implantation site and excessive tension on the mesh due to chronic coughing may have induced the observed tears and holes.Based on the instructions for use (ifu) that accompany the device, it is stated that if the surgical implant is shaped too small for the defect, excessive tension may be placed on the sutures and possibly result in recurrence of the original tissue defect or development of a defect in the adjacent tissues.As the device was cut prior to implantation, it is not known if there was adequate overlap to ensure sufficient margins for incorporation to the surrounding tissues.A review of the device history record (dhr) has been performed.This review confirmed that this lot of products was reviewed and released according to quality specifications, including records related to bioburden and sterilization.Should additional information become available, the record will be re-evaluated and amended as needed.
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