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-OCT-2016) IS CONSIDERED TO BE A BEST ESTIMATE. THIS EMDR REPRESENTS THE PHASIX FLAT MESH (DEVICE 4). ADDITIONAL SUPPLEMENTAL EMDRS AND EMDRS WERE SUBMITTED TO REPRESENT THE VENTRALIGHT ST MESH (DEVICE 1), VENTRALIGHT ST (DEVICE 2) AND VENTRIO ST (DEVICE 3). 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: ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCARCERATED INFRAUMBILICAL AND PERIUMBILICAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST (DEVICE 1). PER OP NOTES, ¿A LARGE INCARCERATED INCISIONAL HERNIA AT THE LEVEL OF UMBILICUS. THE HERNIA WAS REDUCED. THE INCARCERATED OMENTUM WAS REDUCED. A VENTRALIGHT ST (DEVICE 1) WAS PLACED AND TACKED.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH EXCISION OF VENTRALIGHT ST (DEVICE 1) AND IMPLANT OF VENTRALIGHT ST (DEVICE 2), VENTRIO ST (DEVICE 3). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND ADHERENT TO ABDOMINAL WALL. THE CONTENTS OF HERNIA SAC WERE REDUCED. THE FAILED PRIOR MESH (DEVICE 1) WAS RESECTED. THE HERNIA SAC ALSO EXCISED. A VENTRALIGHT ST (DEVICE 2) WAS PLACED AND INTRA-ABDOMINAL CAVITY AND SECURED WITH SUTURES. THE VENTRIO ST (DEVICE 3) WAS PLACED AND TACKED.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH FASCIAL DEHISCENCE WITH SMALL BOWEL EVISCERATION THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALIGHT ST (DEVICE 2), VENTRIO ST (DEVICE 3) AND IMPLANT OF PHASIX MESH (DEVICE 4), XENMATRIX AB (DEVICE 5). PER OP NOTES, ¿THE PREVIOUSLY PLACED MESHES (DEVICE 2 AND 3) WERE REMOVED. THE PRIOR TACKS WERE REMOVED. A XENMATRIX (DEVICE 5) WAS PLACED IN THE INTRA-ABDOMINAL CAVITY AND SECURED WITH TACKS. PHASIX MESH (DEVICE 4) WAS PLACED AS ONLAY AND SECURED USING SUTURES.¿ ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF PHASIX MESH (DEVICE 4) AND IMPLANT OF BIOLOGICAL MESH. PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND EXCISED. ADHESIONS WERE LYSED. THE PRIOR MESH (DEVICE 4) WAS EXCISED. A BIOLOGICAL MESH WAS PLACED AND SUTURED.¿