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. THIS MDR REPRESENTS THE PHASIX MESH (DEVICE 2). AN ADDITIONAL MDR WAS SUBMITTED TO REPRESENT THE VENTRIO ST MESH (DEVICE 3). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE VENTRALIGHT ST MESH (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) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE 1) AND A PHASIX MESH (DEVICE 2). PER OP NOTES, "AN UNKNOWN MESH WAS REMOVED. A VENTRALIGHT ST MESH (DEVICE 1) WAS PLACED TO COOPER'S LIGAMENT AND SECURED INSIDE THE FASCIA OF THE RECTUS MUSCLES DOWN INTO THE PELVIS. IN THE ABDOMINAL WALL PLACED A PHASIX MESH (DEVICE 2) TO THE FASCIA." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE 1 AND 2) AND IMPLANT OF VENTRIO ST MESH (DEVICE 3). PER OP NOTES, "SEVERE ADHESIONS NOTED. THE OLD MESH WAS ATTACHED TO THE FASCIA, AND THE MESH WAS SPLIT IN HALF. ONCE THIS WAS DONE, REMOVED A PIECE OF THE MESH (DEVICE 1 AND 2). A VENTRIO ST MESH (DEVICE 3) WAS PLACED TO THE SUPRAPUBIC AND COOPER'S LIGAMENT ON BOTH SIDES." (B)(6) 2018 - PATIENT HAD RIGHT LOWER QUADRANT PAIN THEREBY UNDERWENT REPAIR WITH THE REMOVAL OF MESH (DEVICE 3) AND IMPLANT OF PHASIX ST MESH (DEVICE 4) AND ADHESIOLYSIS. PER OP NOTES, "ADHESIONS WERE SEVERE. DETACHED THE MESH (DEVICE 3) FROM THE SMALL BOWEL. PUBIS, COOPER'S LIGAMENT AND THE ILIAC BONE WERE DISSECTED. A PHASIX ST MESH (DEVICE 4) WAS PLACED TO THE PUBIC BONE."