Description of Event or Problem · 1
DR IMPLANTED A LEFT SUPERFICIAL FEMORAL ARTERY TO COMMON FEMORAL VEIN SYNERGRAFT FOR DIALYSIS ACCESS. EVER SINCE PT HAD A CORONARY ARTERY BYPASS GRAFT SEVERAL YEARS AGO AND SUSTAINED A MEDIASTINITIS WITH A STERNAL WOUND DEHISCENCE COMPLICATED BY MRSA, NEARLY EVERY OTHER SUBSEQUENT OPERATION PT HAS HAD, MOST OF WHICH HAVE BEEN FOR DIALYSIS ACCESS GRAFTS, HAS BEEN COMPLICATED BY MRSA INFECTIONS. PT EVEN DEVELOPED AN MRSA INFECTION IN THEIR SAPHENECTOMY SITE IN RIGHT LEG SEVERAL YEARS AFTER CORONARY ARTERY BYPASS GRAFT. FOR THIS REASON, THEY IMPLANTED A BIOLOGIC GRAFT IN LEFT LEG. THIS GRAFT IS MADE BY THE CRYOLIFE CO. AT THE TIME OF THIS GRAFT IMPLANTATION, THERE WERE NO KNOWN ISSUES WITH CRYOLIFE PRODUCTS. SINCE THAT TIME, DR BELIEVES THREE PTS HAVE BECOME INFECTED WITH CRYOLIFE TENDON GRAFTS AND THE FDA HAS RECALLED ALL CRYOLIFE PRODUCTS, INVOLVING TISSUES HARVESTED IN 2001. ALTHOUGH THE DEVICES IN QUESTION WERE TENDON GRAFTS, NOT VEIN GRAFTS, THE FDA HAS RECALLED ALL CRYOLIFE PRODUCTS. AFTER PT'S IMPLANT HERE, THEY INITIALLY DID WELL. THE VEIN HAS ALWAYS REMAINED PATENT, BUT PT WAS RECENTLY ADMITTED FOR A LEFT GROIN INFECTION AND A SUPERFICIAL WOUND DEHISCENCE. DR DEBRIDED THE LEFT GROIN, PULSE EVACED IT AND PLACED A SARTORIUS MUSCLE FLAP OVER A SEGMENT OF EXPOSED CRYOVEIN. THE VEIN GRAFT DID NOT APPEAR TO BE CLINICALLY INFECTED. HOWEVER, DEBRIDEMENT OF THE TISSUES WAS PERFORMED AND CULTURES WERE SENT AND THEY RETURNED POSITIVE FOR E-COLI, PROTEUS AND COAGULASE-NEGATIVE STAPHYLOCOCCUS. THE PT WAS PLACED ON GENTAMICIN AND A CEPHALOSPORIN. THE FOLLOWING DAY, THE PT BEGAN TO BLEED FROM THE LEFT GROIN AND WAS TAKEN TO THE OR BY DR'S PARTNER. THE CRYOLIFE SYNERGRAFT WAS THE BLEEDING SITE AND REQUIRED SUBTOTAL EXCISION AND RECOVERAGE OF THE INFECTED AREA IN THE GROIN WITH A SARTORIUS FLAP. AGAIN, CULTURES GREW E-COLI AND PROTEUS, NOT MRSA OR CLOSTRIDIA. IT IS DR'S OPINION THAT THIS INFECTION WAS PT RELATED. PT HAS HAD CHRONIC WOUND AND SKIN PROBLEMS. THE FISTULA HAD TO BE REPLACED IN THE LEFT GROIN DUE TO LACK OF UPPER EXTREMITY SITES. GROIN SURGERY INCREASES THE RISK OF INFECTION. DR DOES NOT BELIEVE THIS COMPLICATION WAS DIRECTLY RELATED TO THE CRYOLIFE PRODUCT, BUT THEY WANTED TO CALL THIS ISSUE TO FDA'S ATTENTION SINCE THIS PRODUCT HAS SINCE BEEN RECALLED. THE PT IS RECOVERING WELL AND DR DOESN'T BELIEVE THEY WILL HAVE ANY LONG TERM SEQUELA FROM THIS EVENT, HOWEVER, THEY WILL BE A CHRONIC DIFFICULT HEMOACCESS PROBLEM SINCE DR HAD TO PARTIALLY REMOVE THEIR MOST RECENTLY PLACED CRYOLIFE VEIN ACCESS AND PT NOW HAS TO RELY SOLEY ON A CATHETER.