As reported, it is alleged that about 10 months post implant of the bard/davol ventrio mesh, the patient had a reaction to the ptfe component, fluid collection positive for bacteria.It was also reported that the patient had subsequent surgical intervention for removal of the ptfe component.Due to privacy laws in (b)(6), contact information was not provided, as such we are unable to request additional information.Based on the limited information provided, we are unable to determine to what extent, the bard device may be causing or contributing to the reported postoperative symptoms.No lot number has been provided; therefore, a review of the manufacturing records is not possible.The instructions-for-use (ifu) supplied with the device lists seroma, infection and allergic reaction as possible complications.In regards to the infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis." should additional information be provided, a supplemental mdr will be submitted.
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The following was reported via tga report (australia fda): "device impacted (implanted) (b)(6) 2019, and explanted (b)(6) 2020.Body reacted to white plastic coating on mesh - ptfe.Continuous build up of fluid if¿s with multiple sinus opening to allow the fluid to escape.The ptfe coating was removed in (b)(6) 2020.At this time the ptfe component was removed from the bard ventrio mesh 13.8 x 17.8 cm.Wound drain fluid stain positive for a modified zen strain, possibly nocardia.But, no bacteria actually grown on culture.".
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