ARTEGRAFT WAS NOT ABLE TO MATCH THE ISSUES FROM THE JOURNAL ARTICLE TO ANY PREVIOUS COMPLAINTS FROM 2011 TO PRESENT. NO DEVICE EVALUATION WAS ABLE TO BE PERFORMED BECAUSE THE DEVICES WERE NOT RETURNED AND NO LOT NUMBERS WERE PROVIDED. ARTEGRAFT, INC. IFU ADVERSE REACTION SECTION STATES THAT STEAL SYNDROME AND ANEURYSMS ARE KNOWN COMPLICATIONS WITH THE ARTEGRAFT. THE COMPLAINT ISSUE WILL CONTINUE TO BE MONITORED WITHIN ARTEGRAFT, INC. QUALITY SYSTEMS, QUALITY ASSURANCE TRENDING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
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Patient 1
LITERATURE REVIEW OF JOURNAL REPRINT TITLED: BOVINE CAROTID ARTERY BIOLOGIC GRAFT OUTPERFORMS EXPANDED POLYTETRAFLUOROETHYLENE FOR HEMODIALYSIS ACCESS. A RETROSPECTIVE ANALYSIS WAS PERFORMED OF ALL PATIENTS WHO RECEIVED AVGS FOR DIALYSIS ACCESS BECAUSE THEY WERE NOT CANDIDATES FOR NATIVE AVF AT JOHNS HOPKINS BAYVIEW MEDICAL CENTER BETWEEN JANUARY 01 2011 AND JUNE 30 2014. THE STUDY REVIEWED 120 CONSECUTIVE GRAFTS PLACED IN 98 PATIENTS; 52 WERE BCA (BOVINE CAROTID ARTERY). THE BCA GRAFT USED WAS THE ARTEGRAFT (ARTEGRAFT, INC. (B)(4)). RESULTS MENTIONED STEAL OCCURRED IN TWO BCA GRAFTS (4%) AND PSEUDOANEURYSMS OCCURRED IN TWO BCA GRAFTS (4%). ADDITIONALLY, IT WAS STATED THAT THE INFECTION RATE DURING THE STUDY PERIOD WAS 15% FOR BCA. THE STUDY DID NOT TAKE INTO ACCOUNT MEDICATION USE OR THE TYPE AND NUMBER OF PRIOR VASCULAR ACCESSES AND THE EFFECT THIS MIGHT HAVE ON SUBSEQUENT GRAFT ABANDONMENT.