[2879299]
Intraoperative episode of myocardial ischemia, hemodynamic compromise and poor pulse in the lad. Initial report received from cardiac surgeon via a sales representative on (b)(6) 2012 and subsequently via phone call on (b)(6) 2012, regarding a (b)(6) male pt with a pmh of multiple left anterior descending artery (lad) and right coronary artery (rca) stentings, and a recent angiogram showing 40% stenosis of left main artery, and suggested anterior wall revascularization while his rca stenting area looked fine. In addition the pt had an ejection fraction of approximately 40%, a 50-69% left carotid stenosis, and mild aortic disease. Vessels diameters were reported as: maximal ascending aortic diameter of 3. 65 cm. The lad diameter was 2 mm, the obtuse marginal artery (om) diameter was 2. 25 mm. The pt was experiencing recurrent angina and had a positive stress test on an unk date. He underwent an off-pump cabg on (b)(6) 2012. The surgeon planned to do an end-to-side anastomosis on the target vessels. Legoo cs-50 (0. 5ml syringe) was injected into the lad. The surgeon estimated that of the provided volume, approx 3/4 of legoo was injected proximally and 1/4 distally to help hemostasis. The left internal mammary artery (lima) was snared proximally to the lad. Cold saline irrigation was used to dissolve the legoo. Legoo plugs washed and flow was good, the final suture was tied down. During positioning of the heart to expose the om, a hemodynamic compromise was noted ("the pt was struggling"), and the surgeon noticed a poor pulse in the lad, considered as an episode of intraoperative myocardial ischemia. This prompted the surgeon to perform another vein graft to the lad distal to the lima graft (bridge graft). After placing this graft, the pt improved. No ekg changes were noted during the ischemic period or postoperatively, and the cardiac enzymes were negative postoperatively. The surgeon continued the procedure and the om was then grafted. In total the following grafts were performed: lima to lad; saphenous vein graft to lad, saphenous vein graft to om. The pt had an uneventful post-operative course. The surgeons' assessment of the relation of intraoperative episode of myocardial ischemia and legoo was possibly related. Summary of complaint investigation report: lot history records were reviewed and there were no deviations or non-conformances that would effect the quality of lot 062312-02. The lot met release specifications.
Patient Sequence No: 1, Text Type: D, B5