The subject device was returned for evaluation.The sample evaluation confirms sections of the hydrogel coating have stuck together causing voids in the hydrogel material.As reported the mesh was not hydrated prior to insertion.If the mesh is not hydrated per the instructions-for-use, portions of the hydrogel can become hydrated by bodily fluids during insertion.When this happens the dry portion of the hydrogel barrier will to stick to the hydrated portion making deployment and placement difficult and causing separation of the hydrogel barrier.The sample evaluation found no manufacturing anomalies.This complaint is confirmed for a use related issue.Review of manufacturing records indicate product was manufactured to specification.No manufacturing anomalies were found.To date, this is the only reported complaint for this manufacturing lot of 189 units released for distribution in june, 2019.
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It was reported that, on (b)(6) 2020, the bard/davol ventralight st w/ echo positioning system was used during a laparoscopic ventral hernia repair procedure.The mesh was not hydrated, and no sutures were applied.The mesh was rolled with the barrier/echo ps¿ positioning system facing in and inserted via a 12 mm trocar.The mesh was tacked using 6 (six) bard/davol optifix clips; when the tacker was being placed, the hydrogel barrier peeled off from the mesh and did not allow the mesh to be in contact with the bowel.There was a delay in procedure, and a new ventralight st mesh was used to complete the procedure.Patient was discharged few hours later and there was no reported patient injury.The surgeon is an experienced user of the device.
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