Description of Event or Problem · 1
THE PATIENT PRESENTED WITH A MIDLINE INCISIONAL HERNIA AND AN UPPER RIGHT QUADRANT (URQ) HERNIA FROM WHICH THE LIVER AND GALLBLADDER WERE PROTRUDING. ON (B)(6)2010, THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) AT WHICH TIME THE PHYSICIAN REMOVED A PREVIOUS MIDLINE SCAR. IT WAS BELIEVED THAT THE LIVER AND GALLBLADDER WERE PROTRUDING FROM A PREVIOUS LAPAROSCOPY SCAR OR THE SITE OF THE PREVIOUS ILEOSTOMY, RATHER THAN THE MIDLINE INCISION. UPON ENTERING THE PATIENT'S ABDOMEN, THE PHYSICIAN NOTED THAT AN UNSPECIFIED SIZE OF A SURGICAL MESH HAD BEEN IMPLANTED, HOWEVER, THE LOCATION OF THE MESH IS UNKNOWN AND THE MESH WAS NOT REMOVED DURING THIS PROCEDURE. ADDITIONALLY, THE PHYSICIAN NOTED THAT A SECTION OF THE PATIENT'S SMALL BOWEL HAD BEEN STITCHED TOGETHER DURING A PREVIOUS PROCEDURE AND THE SUTURES WERE "POKING THROUGH", CREATING A FISTULA. A SMALL BOWEL RESECTION WAS PERFORMED UTILIZING THREE FIRINGS OF A LINEAR STAPLER WITH BLUE STAPLER LOADS AND 3-0 VICRYL SUTURE. THE PHYSICIAN IMPLANTED A 12X25 PIECE OF VERITAS COLLAGEN MATRIX WITH A #1 PROLENE SUTURE TO REPAIR BOTH THE MIDLINE AND URQ HERNIAS. NO COMPLICATIONS WERE REPORTED. ON 07/22/2010, THE PHYSICIAN REPORTED THAT THE PATIENT WAS DOING WELL AND REMAINED WITHOUT COMPLICATION, HOWEVER, IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED SOME EPISODES OF COUGHING AND THE ABDOMINAL BINDER REQUIRED MULTIPLE CHANGES. ON (B)(6)2010, THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND GREEN COLORED OOZE FROM THE INCISION AND WAS TAKEN BACK TO THE OPERATING ROOM. UPON EXPLORATION OF THE ABDOMEN, THE PHYSICIAN NOTED THAT THE VERITAS PATCH HAD "RIPPED" FROM THE LEFT SIDE PERIMETER OF THE ABDOMEN AND A SMALL BOWEL PERFORATION WAS NOTED. ADDITIONALLY, THE VERITAS PATCH DID NOT APPEAR TO HAVE INCORPORATED INTO THE HOST TISSUE AND THERE WAS EVIDENCE OF INFECTION, INFLAMMATION AND FOREIGN BODY REACTION. THE VERITAS PATCH WAS EXPLANTED, THE SMALL BOWEL PERFORATION WAS REPAIRED, AND AN ALTERNATIVE MESH WAS IMPLANTED IN THE SAME MANNER AS THE VERITAS PATCH HAD BEEN IMPLANTED. THE PATIENT'S CURRENT STATUS IS UNKNOWN, HOWEVER, IT WAS NOTED THAT AS OF 08/04/2010, THE PATIENT HAD NOT RETURNED TO THE OR FOR FURTHER SURGICAL INTERVENTION. FOLLOWING THE PROCEDURE, THE PHYSICIAN "PULLED' ON EACH SIDE OF THE EXPLANTED VERITAS PATCH AT WHICH TIME THE PATCH RIPPED IN THE MIDDLE. IT WAS NOTED THAT THE PATCH CONTAINED A "GREENISH HUE" DUE TO CONTAMINATION OF THE ABDOMEN FROM THE LEAKAGE OF BOWEL CONTENTS. A SAMPLE OF THE EXPLANTED VERITAS PATCH WAS SENT TO SYNOVIS. THE SAMPLE UNDERWENT A VISUAL EXAMINATION. NO ROOT CAUSE FOR THE INCIDENT WAS ABLE TO BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED. ACCORDING TO THE DEVICE HISTORY RECORD, THE DEVICE MET SPECIFICATION AT THE TIME OF MANUFACTURE.