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Patient 1
DEVICE 2 OF 2; REFER TO MDR-2247686-2018-00002 FOR DEVICE 1 OF 2. THE TWO ARTEGRAFT (COLLAGEN VASCULAR GRAFTS) WERE NOT RETURNED TO ARTEGRAFT, INC. FOR EVALUATION AS THEY REMAIN IMPLANTED. A REVIEW OF THE PRODUCTION BATCH RECORD WAS PERFORMED; NO ANOMALIES WERE IDENTIFIED. ALL GRAFTS RELEASED FROM PRODUCT BATCH 16J215 PASSED ALL OF THE REQUIREMENTS INCLUDING PRESSURE TESTING AND STERILITY TESTING PRIOR TO FINAL RELEASE TO FINISHED GOODS. IN FOLLOW-UP CONVERSATIONS BETWEEN THE DISTRIBUTOR REPRESENTATIVE AND THE SURGEONS' STAFF AT (B)(6) HOSPITAL, IT WAS STATED THAT THE TAMPER EVIDENT SEAL WAS IN PLACE ON THE BOX , THE SHRINK WRAP WAS PRESENT ON THE TUBE PRIOR TO USE, AND THE GRAFT WAS PREPARED PER THE IFU PRIOR TO USE. ARTEGRAFT, INC. MAILED A CERTIFIED LETTER TO (B)(6) HOSPITAL REQUESTING ADDITIONAL INFORMATION RELATED TO THE EVENTS. TO DATE, NO ADDITIONAL INFORMATION WAS PROVIDED. ARTEGRAFT, INC. CHIEF MEDICAL OFFICER (QUALIFICATION: M.D., F.A.C.S.) REVIEWED THE CASE DETAILS AND STATED THAT "IN THE EVENT THAT A WOUND INFECTION OCCURS IN THE AREA OF THE ARTEGRAFT, INCREASED SURVEILLANCE MUST BE UNDERTAKEN. GRAFT IS COLLAGEN. COLLAGEN MAY BREAK DOWN IN THE PRESENCE OF PSEUDOMONAS, MRSA, E. COLI." ARTEGRAFT, INC. IFU DOSAGE AND ADMINISTRATION SECTION PROVIDES INSTRUCTIONS FOR ASEPTICALLY REMOVING THE ARTEGRAFT FROM ITS CONTAINER. ADDITIONALLY, THE ADVERSE REACTION SECTION STATES "DISRUPTION OF ANASTOMOSES, ESPECIALLY IN THE PRESENCE OF INFECTION, HAS BEEN OBSERVED AND, IN A FEW CASES, TRANSIENT LOW GRADE FEVER, THE ETIOLOGY, OF WHICH HAS NOT BEEN OBVIOUS, HAS BEEN EXPERIENCED." NO CONFIRMED COMPLAINT TREND WAS IDENTIFIED RELATED TO THE ISSUE. ALL PRODUCT QUALITY AND CLINICAL ISSUES WILL CONTINUE TO BE MONITORED WITHIN ARTEGRAFT, INC. QUALITY SYSTEMS, QUALITY ASSURANCE TRENDING.