Description of Event or Problem · 1
TRIAL IMPLANT FORTIVA SPLIT STRAIGHT DOWN THE MIDDLE AT THE END OF IMPLANTATION REQUIRING ITS REMOVAL AND ADDITION OF 1 HOUR OPERATIVE TIME TO RE-IMPLANT STRATTICE.MANUFACTURER RESPONSE FOR FORTIVA PORCINE DERMIS 20 X 20, FORTIVA PORCINE DERMIS (PER SITE REPORTER).======================THANK YOU FOR THE EMAIL. I HAVE JUST A COUPLE OF QUESTIONS BUT WILL RELY ON OUR QA GROUP TO ASK FURTHER QUESTIONS IN ORDER TO FULFILL WHAT THEY NEED FOR THE INVESTIGATION...BEFORE I ASK, I WOULD LIKE TO CONFIRM MY UNDERSTANDING OF WHAT HAPPENED (IN SHORT - PLEASE FEEL FREE TO PROVIDE MORE INFORMATION IN GENERAL). FORTIVA WAS BEING SUTURED IN AT THE END OF THE CASE AND WHEN ONE OF THE LAST SUTURES WAS PLACED A TEAR DEVELOPED IN THE IMPLANT. THE TEAR COULDN'T BE SEWED TOGETHER DUE TO ADDITIONAL TEARING, CORRECT? THAT IS CORRECT, AS WE TRIED TO SEW THE FORTIVA, IT CONTINUED TO SPLIT SO WE HAD TO ABANDON THE ATTEMPT.- DID YOU NOTICE IF THE IMPLANT WAS THIN AT ANY SPOT, PARTICULARLY WHERE THE TEAR OCCURRED?THE IMPLANT APPEARED UNIFORMLY THE SAME THICKNESS THROUGHOUT THE GRAFT- WAS THE AMOUNT OF PRESSURE NEEDED TO SUTURE CONSISTENT ALL THE WAY AROUND THE IMPLANT OR WAS IT SIGNIFICANTLY EASIER IN SOME SPOTS THAN OTHERS? THE AMOUNT OF PRESSURE REQUIRED ON THE NEEDLE WAS UNIFORM THROUGHOUT- WHAT KIND OF SUTURE NEEDLE WAS BEING USED, I.E., TAPER OR CUTTING?I ALWAYS USED TAPERED NEEDLES ON GRAFT- WE USED THE SAME NEEDLE WE WOULD USE ON FASCIA, #1 PDS ON A CTX NEEDLE?- WHAT WAS THE DISTANCE OF BITE TAKEN AND DID THE SUTURE ACTUALLY PULLOUT FROM THE BITE TO THE EDGE OF THE IMPLANT?WE SPACE THE SUTURES ABOUT 1.5 CM FROM ONE ANOTHER, TAKE 1-2CM U STITCH BITES THROUGH THE GRAFT THAT ARE PULLED TRANSFASCIALLY, AS IS THE STANDARD FOR ALL ABDOMINAL WALL RECONSTRUCTIONS.- WAS THE IMPLANT STILL MOIST / PLIABLE AT THE TIME THE TEAR DEVELOPED?THE GRAFT WAS STILL PLIABLE/MOIST, WHEN REPAIRED (WE REHYDRATE THE GRAFT WITH SALINE DURING THE REPAIRS SO THEY NEVER DESSICATE.- WAS THE IMPLANT USED TO BRIDGE AND / OR WAS THE IMPLANT UNDER HIGH TENSION WHILE BEING SUTURED?THE IMPLANT WAS NOT USED TO BRIDGE- IT WAS BEING PLACED AS A SUBLAY MESH TO REINFORCE THE CLOSURE OF FASCIA OVER IT. IT WAS UNDER NO HIGHER TENSION THAN ANY OF THE RECONSTRUCTIONS DO WHERE I DO BILATERAL MYOFASCIAL FLAPS FOR CLOSURE OF THE MIDLINE.- WAS THE IMPLANT IN THE PRESENCE OF PANCREATIC FLUID OR INFECTION WHILE SUTURING?IT WAS NOT - THIS WAS A CLEAN, UNCONTAMINATED FIELD.THANK YOU FOR YOUR HELP!