Versatex

Description of Event or Problem

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a incisional ventral hernia. It was reported that after implant, the patient experienced adhesions, infected mesh, fibrous tissue, non-healing wound, chronic drainage from periphery of flap, mesh bunched, mesh poorly incorporated, mesh fracture with bowel protruding through, four draining wounds , pus draining from mesh. Post-operative patient treatment included flap elevation of previously transferred free flap, washout of abdominal wound, excision of abdomen wound, mesh revision, partial mesh removal, lysis of adhesions, reconstruction of abdomen.

Additional Manufacturer Narrative

Medtronic submits this report to comply with FDA regulations 21 CFR Parts 4 and 803. Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by FDA, Medtronic, or its employees that the device, Medtronic, or its employee caused or contributed to the event described in the report. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. Medtronic will submit a supplemental report if additional relevant information becomes known.