Description of Event or Problem · 1
MYOCARDIAL INFARCTIONS (MI). IN 2002, THIS PATIENT WAS REFERRED FOR HIGH-RISK BYPASS SURGERY FOR THREE-VESSEL CORONARY ARTERY DISEASE AND AN EJECTION FRACTION OF 40%. THE PATIENT UNDERWENT BYPASS SURGERY WITH LEFT INTERNAL MAMMARY ARTERY PLACED TO THE LAD AND SEQUENTIAL GRAFT TO TWO OBTUSE MARGINALS, WHICH WAS THEN PLACED TO THE SIDE OF THE LEFT INTERNAL MAMMARY ARTERY. FOCALSEAL L WAS APPLIED ON 3 DISTAL ANASTOMOSES AND 1 PROXIMAL ANASTOMOSIS TO THE LEFT INTERNAL MAMMARY ARTERY BED, AND TO THE HEART SURFACE IN AN AREA WHERE THE DISSECTION OCCURRED. THE PATIENT'S POST OPERATIVE COURSE WAS UNEVENTFUL AND PT WAS DISCHARGED 3 DAYS LATER. THE PATIENT EXPERIENCED WEAKNESS AND LOSS OF APPETITE SINCE THEIR DISCHARGE AND 17 DAYS POST DISCHARGE, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH AN ABNORMAL EKF, RAPID ATRIAL FIBRILLATION, MILD HEART FAILURE AND EVIDENCE OF RECENT ANTERIOR MYOCARDIAL INFARCTION OF UNKNOWN DURATION. ENYZMES FROM LAB WORK WERE NEGATIVE. DURING THE PT'S RE-HOSPITALIZATION, CARDIAC CATHETERIZAITON DEMONSTRATED AN EJECTION FRACTION OF 15-20% WITH AN EXTENSIVE ANTEROAPICAL WALL MOTION ABNORMALITY. THE RIGHT CORONARY ARTERY HAD NO SIGNIFICANT DISEASE. PT'S LEFT INTERNAL MAMMARY ARTERY WAS PATENT BUT WAS OCCLUDED DISTAL TO THE ANASTOMOSIS OF THE LAD. IT WAS ELECTED TO TREAT THE PATIENT MEDICALLY. THE PATIENT WAS DISCHARGED IN GOOD CONDITION 8 DAYS LATER. THE PATIENT WAS LAST SEEN ON 06/2002 AND FOUND TO BE DOING MUCH BETTER. THE REPORTING PHYSICIAN ASSESSED THE EVENT AS POSSIBLY RELATED TO THE USE OF THE PRODUCT. FOCALSEAL APPLICATOR KIT PART # FA1645 L/N 0110617 WAS USED TO APPLY THE FOCALSEAL L. MANUFACTURE DATE OF THE APPLICATOR KIT WAS NOV-2001, EXPIRATION SEPT-2003.