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 7). AN ADDITIONAL SUPPLEMENTAL EMDR WERE SUBMITTED TO REPRESENT THE BARD/DAVOL MESH -VENTRALEX MESH (DEVICE 1, 2), XENMATRIX AB (DEVICE 3), PHASIX ST MESH (DEVICE 4) AND ADDITIONAL MDRS WERE SUBMITTED TO REPRESENT PHASIX ST MESH (DEVICE 5, 6) NOTE: SECTION 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) 2008: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, ¿A MODERATE SIZED HERNIA WAS NOTED. THE MESH DID SEEM TO BE PULLED TO THE RIGHT, AND THE HERNIA DEFECT WAS TO THE LEFT. THE HERNIA SAC WAS EXCISED. A LARGE VENTRALEX MESH (DEVICE 1) WAS PLACED INTO DEFECT AND SUTURED.¿ (B)(6) 200: PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OP NOTES, ¿THE BOWEL WAS DISSECTED FROM THE INTERNAL PORTION OF SAC, MESH AND ABDOMINAL WALL. SEVERAL MESH (DEVICE 1) PARTICLES WERE REMOVED. THE BOWEL WAS TAKEN DOWN FROM ADHESION. A VENTRALEX MESH (DEVICE 2) WAS PLACED AND SEWN INTO STRONG FASCIA.¿ (B)(6)2016: PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 2) AND IMPLANT OF XENMATRIX AB (DEVICE 3). PER OP NOTES, ¿THE PATIENT HAD HAD NUMEROUS HERNIAS REPAIRED IN THE PELVIS SECONDARY TO C-SECTIONS. SMALL DILATED LOOPS OF BOWEL WERE NOTED. A CHRONICALLY INCARCERATED UMBILICAL HERNIA WAS FOUND PROXIMAL TO MESH WHERE OBSTRUCTION WAS NOTED. ADHESION WAS NOTED AND MESH (DEVICE 2) WAS RESECTED. THE BOWEL ADHERENT TO MESH WAS FREED AND SMALL LOOPS OF BOWEL WAS TRANSECTED. APPENDECTOMY WAS DONE. A XENMATRIX AB (DEVICE 3) WAS IMBRICATED TO DEFECT BELOW THE UMBILICUS USING SUTURES.¿ (B)(6) 2016: PATIENT WAS DIAGNOSED WITH POSTOPERATIVE WOUND INFECTION, ABSCESS, FASCIAL DEHISCENCE THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 3). PER OP NOTES, ¿PATIENT HAD BEEN NOTICED TO BE DRAINING SOME PURULENT MATERIAL IN THE SUPERIOR ASPECT OF THE INCISION DESPITE NO ERYTHEMA. ABSCESS TRACKING FROM INFERIOR TO SUPERIOR ASPECT WAS DRAINED. PREVIOUSLY PLACED SUTURES WAS COMPLETELY DEHISCED FOR THE ENTIRE LENGTH OF THE INCISION AND THE SUTURES WERE JUST BASICALLY LYING IN THE FIELD. THERE WAS SOME NECROTIC FASCIA IN THE CENTRAL AREA OF THE REGION, AND WHERE THE XENMATRIX AB WAS PLACED INFERIORLY. THE MESH (DEVICE 3) WAS ESSENTIALLY DESTROYED AND DIGESTED FROM PROTEOLYTIC ENZYMES OF BACTERIA. THE SUTURES LYING IN FIELD WAS REMOVED ALONG WITH NONVIABLE MESH (DEVICE 3).¿ (B)(6) 2017: PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF PHASIX ST MESHES (DEVICE 4, 5). PER OP NOTES, ¿INCISION WAS MADE AROUND THE PREVIOUS SCAR INCLUDING HERNIA SAC FROM THE JUST ABOVE THE SYMPHYSIS TO JUST BELOW THE XIPHOID PROCESS. INTRA-ABDOMINAL ADHESIONS WAS UNDERTAKEN. A PHASIX ST MESHES (DEVICE 4, 5) WERE CHOSEN FOR BUTTRESSING THE REPAIR OF FASCIA. THE MESHES WERE PLACED INTRABDOMINAL AND SECURED TO ANTERIOR ABDOMINAL WALL LATERAL TO MIDLINE USING SUTURES.¿ (B)(6) 2021:PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL INCISIONAL HERNIA, ENTEROPROSTHETIC CUTANEOUS FISTULA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESHES (DEVICE 4, 5). PER OP NOTES, ¿MIDLINE LAPAROTOMY WAS PERFORMED ENCOMPASSING OLD SCAR AND FISTULA. DENSE ADHESIONS WERE LYSED. SEVERAL AREAS OF LOOPS OF BOWEL WAS IDENTIFIED IN DRAINING SINUSES. THE BOWEL WAS INGROWN INTO PREVIOUSLY PLACED MESHES AND WAS INSEPARABLE. THE INVOLVED INTESTINES WERE RESECTED ALONG WITH MESHES (DEVICE 4, 5) AND SIDE TO SIDE ANASTOMOSIS WAS PERFORMED. A BILATERAL ANTERIOR COMPONENT SEPARATION WAS DONE. SOFT TISSUE REARRANGEMENT WAS DONE TO COVER THE REPAIR.¿ (B)(6) 2021: PATIENT WAS DIAGNOSED WITH ACUTE ABDOMEN AND PERFORATED SMALL BOWEL THEREBY UNDERWENT OPEN SMALL BOWEL RESECTION. PER OP NOTES, ¿A SMALL PERFORATION ALONG THE ENTERO-ENTEROSTOMY WAS DISCOVERED. THE AREA NEAR THE PERFORATION AND ENCOMPASSING BOTH ANASTOMOSIS WAS THEN RESECTED.¿ (B)(6) 2021: PATIENT WAS DIAGNOSED WITH OPEN ABDOMEN THEREBY UNDERWENT DEBRIDEMENT OF NECROTIC MUSCLE. (B)(6) 2021: PATIENT WAS DIAGNOSED WITH OPEN ABDOMEN THEREBY UNDERWENT ILEOCECAL RESECTION. (B)(6) 2021: PATIENT WAS DIAGNOSED WITH OPEN ABDOMEN; SOFT TISSUE INFECTION THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX ST MESH (DEVICE 6). PER OP NOTES, ¿THE WOUND VAC WAS REMOVED. THERE WAS MORE NECROSED SOFT TISSUE WAS DEBRIDED. A PHASIX ST MESH (DEVICE 6) WAS ATTACHED AS AN INLAY AND PARTIAL UNDERLAY USING SUTURES.¿ (B)(6) 2021: PATIENT WAS DIAGNOSED WITH OPEN ABDOMEN; SOFT TISSUE INFECTION THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 6). PER OP NOTES, ¿THERE WAS A PUS EMINATING FROM THE INFERIOR ASPECT OF THE WOUND. THE MESH WAS REMOVED (DEVICE 6) AND THE VISCERA WAS INSPECTED. NECROSED SOFT TISSUE WAS EXCISED.¿ (B)(6) 2021: PATIENT WAS DIAGNOSED WITH OPEN ABDOMEN THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX MESH (DEVICE 7). PER OP NOTES, ¿THERE WAS MINIMAL MURKY ASCITES IN THE RIGHT LOWER QUADRANT. THE SMALL BOWEL WAS DILATED WHICH FORMED INTERLOOP ADHESIONS. A PHASIX MESH (DEVICE 7) WAS PLACED IN A BRIDGING FASHION WITH PARTIAL UNDERLAY AND SECURED USING SUTURES.¿ (B)(6) 2022: PATIENT HAD CHRONIC WOUND AND WAS DIAGNOSED WITH INFECTED MESH, RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 7). PER OP NOTES, ¿THE SMALL BOWEL HAD BEEN LYSED FROM THE MESH AND THE MESH (DEVICE 7) WAS REMOVED. THERE WERE EXTENSIVE INTRA-ABDOMINAL ADHESIONS OF OMENTUM TO BOWEL, AS WELL AS INTER-LOOP ADHESIONS WERE LYSED."