PHASIX MESH

Description of Event or Problem

PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT ROBOTIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE 1). PER OP NOTES, "THE HERNIA AT THE PREVIOUS INCISION SITE WAS NOTED. A PREPERITONEAL FAT STUCK WITHIN THE HERNIA WAS REDUCED. A ROUND VENTRALIGHT ST USING ECHO PS (DEVICE 1) WAS PLACED INTO ABDOMINAL CAVITY AND PULLED UP TOWARDS THE ANTERIOR ABDOMINAL WALL TO HERNIA USING SUTURES." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX MESH (DEVICE 2). PER OP NOTES, "RECURRENT HERNIA AND EVENTRATION OF THE PREVIOUS MESH (DEVICE 1) WAS NOTED. ADHESIOLYSIS WAS PERFORMED. MYOCUTANEOUS FLAPS WERE RAISED TO BRING THE RECTUS MUSCLES BACK TOWARDS THE MIDLINE TO RESTORE ABDOMINAL WALL FUNCTION AND REDUCE PAIN OF THE MESH PROTRUDING THROUGH AND PUTTING PRESSURE ON THE ANTERIOR ABDOMINAL WALL. A PIECE OF PHASIX MESH (DEVICE 2) WAS PLACED AS AN ONLAY AND SECURED DOWN TO FASCIA USING SUTURES." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, ADHESION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST USING ECHO PS MESH (DEVICE 3). PER OP NOTES, "INCISION MADE IN THE RIGHT UPPER QUADRANT TO PREVIOUS PORT SITE. ADHESIONS ON THE SUPERIOR AND INFERIOR ASPECTS OF THE ANTERIOR ABDOMINAL WALL. THERE WERE TWO AREAS OF ADHESIONS ON THE SUPERIOR AND INFERIOR ASPECTS OF THE ANTERIOR ABDOMINAL WALL. A RECURRENT INCISIONAL HERNIA AT THE SUPERIOR ASPECT OF PREVIOUS INCISION. THE MESH APPEARS TO HAVE COMPLETELY EVENT RATED. THE LYSIS OF ADHESIONS WAS PERFORMED. A LARGE VENTRALIGHT ST USING ECHO PS MESH (DEVICE 3) WAS PLACED OVER THE HERNIA DEFECT AND SECURED IN A DOUBLE LAYER OF CROWN TACKING USING SORBAFIX TACKER." (B)(6) 2018 - PATIENT HAD ABDOMINAL PAIN THEREBY UNDERWENT LYSIS OF ADHESION. (NOTE: THE PREVIOUSLY PLACED MESH WAS NOT SEEN DURING THIS PROCEDURE).

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-2015) 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 VENTRALIGHT ST USING ECHO PS (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.