HEMASHIELD GOLD KNITTED

Additional Manufacturer Narrative

(4115/4119/3221) BASED ON AVAILABLE INFORMATION, THE GRAFT WAS EXPLANTED IN 2016. IT WAS ASSUMED THAT THE GRAFT WAS SCRAPPED AND THEREFORE, THE DEVICE IS NOT AVAILABLE FOR EVALUATIONS. IN ADDITION, SINCE THE SERIAL NUMBER AND LOT NUMBER ARE UNKNOWN, HISTORICAL DATA AND DEVICE HISTORY RECORDS CANNOT BE REVIEWED. (4315) DUE TO THE LACK OF INFORMATION, THE CAUSE OF THE REPORTED ADVERSE EVENT COULD NOT ESTABLISHED.

Description of Event or Problem

THIS EVENT WAS SUBMITTED AS PART OF THE INTERVASCULAR PMCF REGISTRY. ON (B)(6) 2016, THE PATIENT PRESENTED WITH A LESION IN THE EXTERNAL AND COMMON ILIAC ARTERIES OF THE BILATERAL LOWER EXTREMITIES. A HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT WAS SOAKED IN HEPARIN BEFORE THE PROCEDURE, AND THE GRAFT WAS IMPLANTED VIA AORTOBIILIAC BYPASS WITHOUT ANY ISSUES. TECHNICAL SUCCESS WAS ACHIEVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2016. ON (B)(6) 2016, 4 MONTHS AND 11 DAYS AFTER THE INITIAL IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A MAJOR ADVERSE LIMB EVENT (INFECTION). THE SEVERITY WAS NOTED AS SEVERE AND THE INVESTIGATOR NOTED THIS WAS CAUSALLY RELATED TO THE STUDY PROCEDURE AND CAUSALLY RELATED TO THE DEVICE. AN INTERVENTIONAL TREATMENT (SURGICAL PROCEDURE) WAS PERFORMED AND THIS ADVERSE EVENT IS NOTED AS RECOVERED WITH SEQUELAE. A SURGICAL PROCEDURE INCLUDING AXILLO-BIFEMORAL BYPASS, REMOVAL OF AORTIC GRAFT, REDO OF AXILLO-BIFEMORAL BYPASS WAS PERFORMED WITH GRAFT REINTERVENTION BUT NO AMPUTATION. THE CLINIC PROVIDED THE FOLLOWING DETAILS, "ON (B)(6) 2016 SUBJECT PRESENTED WITH FEVER, CHILLS, TACHYCARDIAC AND HYPOTENSIVE, COMPUTED TOMOGRAPHY SCAN REVEALED POSSIBLE AORTOENTERIC FISTULA, FLUID COLLECTION IN THE LEFT LOWER QUADRANT, AND SHE WAS BACTEREMIC. SUBJECT UNDERWENT SURGERY WITH GASTROINTESTINAL TEAM FOR CLOSURE OF DUODENAL COMPONENT OF AORTODUODENAL FISTULA. VASCULAR SURGERY THEN TOOK OVER (DR. (B)(6)) OPERATIVE PROCEDURE: TO COMPLETE A RIGHT AXILLOBIFEMORAL BYPASS UTILIZING 8MM PRECONSTRUCTED GRAFT; ABDOMINAL EXPLORATION REMOVAL OF PREVIOUSLY PLACED AORTOBIFEMORAL GRAFT, OVER-SEWING OF THE ABDOMINAL AORTA, REPAIR OF DUODENUM."