PHASIX MESH

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-NOV-2017) IS CONSIDERED TO BE A BEST ESTIMATE. THIS EMDR WAS SUBMITTED TO REPRESENT THE PHASIX MESH (DEVICE #2). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE 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.

Description of Event or Problem

PER INFORMATION PROVIDED: (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA SAC IN MID ABDOMEN WAS IDENTIFIED AND DISSECTED DOWN TO EDGES OF FASCIA. A VENTRIO ST MESH (DEVICE #1) WAS PLACED OVER THE DEFECT AND SUTURED AND STAPLED.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA AND ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF VENTRIO ST MESH (DEVICE #1) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿DENSE ADHESIONS WERE REMOVED. THE MESH (DEVICE #1) APPEARED TO BE CONTRACTED, INDURATED. THE MESH (DEVICE #1) WAS REMOVED. THE RECURRENT INCISIONAL HERNIA WAS IDENTIFIED AND SAC WAS DISSECTED AND SYNTHETIC MESH WAS PLACED AND SUTURED.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿IN LOWER MIDLINE, DENSE SCAR TISSUE WITH ADHESIONS AROUND HERNIA SAC WAS EXCISED. THE RECURRENT HERNIA WAS REPAIRED WITH SUTURES. ¿ (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESH. (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA AND SEROMA OF ABDOMEN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF SYNTHETIC MESH (X2) AND IMPLANT OF PHASIX FLAT MESH (DEVICE #2). PER OPERATIVE NOTES, ¿IN THE MIDLINE, A SEROMA WITH MURKY FLUID WAS ENCOUNTERED. THE SYNTHETIC MESH WAS REMOVED AND ADHESIONS WERE LYSED. THE RECURRENT HERNIA WAS NOTED AND REPAIRED WITH PHASIX FLAT MESH (DEVICE #2) AND SUTURED.¿ (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA AND CHRONIC ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PHASIX FLAT MESH (DEVICE #3). PER OPERATIVE NOTES, ¿SYMPTOMATIC ENLARGING VENTRAL DEFECT IN MIDLINE WAS IDENTIFIED. HERNIA SAC WAS IDENTIFIED AND DISSECTED. MINIMAL ADHESIONS AND SCAR TISSUES WERE REMOVED. FLAPS WERE RAISED AND HERNIA DEFECT WAS IDENTIFIED AND PHASIX FLAT MESH (DEVICE #3) WAS PLACED ON POSTERIOR RECTUS SHEATH. THE ANTERIOR MYOFASCIAL ABDOMINAL WALL WAS CLOSED OVER SUBMUSCULAR MESH (DEVICE #2) AS SANDWICH REPAIR AND THEN REPAIRED.¿