N
Patient 1
WE HAVE NOT RECEIVED THE GRAFT FOR EVALUATION. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE DEFECT. THE PATIENT HAD PRIOR HISTORY OF PERIGRAFT SEROMA (PGS) WITH A DIFFERENT GRAFT ( DIFFERENT MANUFACTURER ) AS WELL THAT WAS INITIALLY USED TO TREAT HIS ABDOMINAL AORTIC ANEURYSM. EVEN AFTER THE PREVIOUSLY IMPLANTED GRAFT (DIFFERENT MANUFACTURER) WAS REPLACED WITH THE ALBOGRAFT POLYESTER VASCULAR GRAFT (CATALOG# AMC1608; LOT# 180381 SERIAL NUMBER# (B)(4)), SKIN ECZEMA AND PERIGRAFT SEROMA PERSISTED. THE PATIENT WAS RESPONSIVE TO A PRESCRIBED MEDICATION FOR MORE THAN A YEAR. PERIGRAFT SEROMA (PGS) IS A RARE COMPLICATION THAT CAN OCCUR AFTER PLACEMENT OF ANY VASCULAR GRAFT. IT IS A COLLECTION OF A STERILE, CLEAR AND ACELLULAR LIQUID AROUND THE PROSTHESIS. THE INCIDENT RATE HAS BEEN ESTIMATED AT 4% IN EXTRA-ANATOMIC BYPASS AND 0.7%-0.8% IN ANATOMIC BYPASS OF THE LOWER LIMBS (2,6). IN A STUDY CONDUCTED BY AJITH K. KADAKOL MD AND HIS TEAM, 111 STUDY SUBJECTS IDENTIFIED BETWEEN 1995-2009 UNDERWENT AN AORTIC RECONSTRUCTION- 13 HAD DACRON GRAFTS WHILE 98 HAD POLYTETRAFLUOROETHYLENE (PFTE) GRAFTS. TWENTY PATIENTS (18%) HAD PGS, ALL OF WHOM HAD PTFE GRAFTS (2). THE CAUSE OF PGS REMAINS UNCLEAR, BUT INVOLVES A FAILURE OF NORMAL GRAFT HEALING/INCORPORATION AND/OR TRANSUDATION OF FLUID THROUGH GRAFT PORES (3,4). SUCH SEROMAS HAVE BEEN NOTED AFTER MOST TYPES OF VASCULAR RECONSTRUCTIONS, BUT HAVE USUALLY BEEN RECOGNIZED AND ASSOCIATED WITH SUBCUTANEOUSLY TUNNELED GRAFTS - AXILLOFEMORAL BYPASS AND DIALYSIS ACCESS GRAFTS (3, 5). OTHER POSSIBLE PREDISPOSING FACTORS HIGHLIGHTED IN THE LITERATURE INCLUDE IMPROPER HANDLING OF THE GRAFT AT THE TIME OF RECONSTRUCTION (1,4), HIGH BLOOD PRESSURE, LOW BLOOD VISCOCITY, AND LOW-GRADE PATIENT ALLERGY TO THE GRAFT MATERIAL(7). 180 ALBOGRAFTS FROM THIS LOT WERE RELEASED FOR SALE. WE HAVE ALREADY SOLD ALL OF THE GRAFTS BETWEEN MARCH 2017 - NOVEMBER 2018. THIS IS THE ONLY COMPLAINT WE HAVE RECEIVED FOR THIS LOT NUMBER. OUR REVIEW OF THE LOT HISTORY RECORDS FOR THIS LOT DID NOT FIND ANY DISCREPANCIES EITHER IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS INCIDENT. ALL OF THE QUALITY CONTROL TESTS PASSED WITH EXPECTED VALUES. SPECIFICALLY, THE PHYSICAL INCUBATION TEST (WHICH MEASURES HOW WELL THE COLLAGEN WAS CROSS-LINKED), BLOOD PERMEABILITY AND WATER PERMEABILITY TESTS, DEMONSTRATED THAT THE GRAFTS FROM THIS LOT PERFORMED AS EXPECTED AT THE TIME OF RELEASE. FROM THE INFORMATION OBTAINED IN OUR INVESTIGATION AND THE SUCCESSFUL LOT TESTING RESULTS NOTED ABOVE, WE BELIEVE THAT THE DEVICE WAS PERFORMING WITHIN ITS SPECIFICATION LIMITS FOR ACCEPTABILITY (GRAFTS HAVE A PERMEABILITY REQUIREMENT OF