POWERWIRE RF GUIDEWIRE

Description of Event or Problem

IN AN ABSTRACT SENT TO US FROM DR. (B)(6) FOR AN UPCOMING PUBLICATION, WE RECEIVED INFORMATION OF THE FOLLOWING INCIDENTS: "IN OUR COHORT, 8 PATIENTS HAD CEAP CLASSIFICATION C3 DISEASE, 5 HAD C4, 1 WITH C5, AND 8 HAD C6 DISEASE. VCSS SCORE AT PRESENTATION WAS 12.8 ± 6.6. RF-WIRE RECANALIZATION WAS SUCCESSFUL IN 18/22 PATIENTS (82%) WITH 16/18 PATIENTS (89%) REPORTING SYMPTOMATIC IMPROVEMENT. 2 MAJOR COMPLICATIONS OCCURRED (9%): 1 CIRCUMFLEX FEMORAL ARTERY PSEUDOANEURYSM REQUIRING THROMBIN INJECTION AND EMBOLIZATION AND 1 DEFORMATION OF PRIOR PTFE-STENT GRAFT REQUIRING PARALLEL STENT CONSTRUCT. TWO MINOR COMPLICATIONS OCCURRED: ASYMPTOMATIC RF-WIRE TRAVERSAL INTO THE ILIAC ARTERY AND PORTAL VEIN ALSO OCCURRED. MEAN HOSPITAL STAY WAS 1.3 DAYS WITH 1 OUTLIER WITH A 10-DAY STAY (PSEUDOANEURYSM PATIENT). " THERE IS NO INFORMATION TO SUGGEST A BMT DEVICE MALFUNCTION OCCURRED, OR THAT THE DEVICE CAUSED THE REPORTED MAJOR COMPLICATIONS. HOWEVER, AS A BAYLIS MEDICAL TECHNOLOGIES DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL TECHNOLOGIES HAS DECIDED TO SUBMIT THIS REPORT.