PHASIX MESH

Description of Event or Problem

PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE #1). PER OPERATIVE NOTES, "MODERATE SIZE RECURRENT INCARCERATED INCISIONAL HERNIA WAS NOTED AND OPENED, INCARCERATED OMENTUM IN THE SAC WAS TEASED. A VENTRIO ST MESH (DEVICE #1) WAS PLACED AND SUTURED." (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF MASS AND IMPLANT OF PHASIX MESH (DEVICE #2). PER OPERATIVE NOTES, "A HERNIA SAC WAS IDENTIFIED AT THE SUPERIOR ASPECT OF THE OLD INCISION WITH INCARCERATED OMENTUM. THE SAC WAS OPENED AND FREED. DENSE ADHERENCE TO THE UNDERLYING ABDOMINAL SURFACE WAS NOTED. A PHASIX MESH (DEVICE #2) WAS PLACED AND SUTURED." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST (DEVICE #3) AND PHASIX MESH (DEVICE #4). PER OPERATIVE NOTES, "A LARGE HERNIA SAC EXTENDED FROM THE SUPERIOR ASPECT OF PREVIOUS REPAIR WAS NOTED AND REMOVED. THE INFERIOR PORTION OF WOUND HAD PREVIOUS MESH (DEVICE #1) WHICH WAS LEFT IN PLACE. THE DEFECT WAS NOTED IN THE CENTER OF THE WOUND. A VENTRIO ST MESH (DEVICE #3) WAS PLACED AND SEWN. A PHASIX MESH (DEVICE #4) WAS PLACED TO COVER THE ENTIRETY AND SUTURED."

Additional Manufacturer Narrative

ROOT CAUSE IS INCONCLUSIVE; NO CONCLUSION CAN BE MADE AS TO THE EXTENT TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COURSE. NOTE, THE MANUFACTURING DATE (15-OCT-2016) IS CONSIDERED TO BE A BEST ESTIMATE. THIS EMDR REPRESENTS THE BARD PHASIX MESH (DEVICE #2). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE BARD VENTRIO ST (DEVICE #1). NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.