[21956368]
This report is to summarize a suspected anaphylactic shock related to ic-green-, indocyanine green-, manufactured by akorn, inc, when used for imaging of coronary artery bypass with the spy intra-operative imaging system in a female patient undergoing a routine off-pump coronary artery bypass surgery with 3 vessel disease. The surgery was conducted in 2007. The subject was non-obese and non-diabetic, who suffered total systemic dilation following a 1 cc iv administration of 2. 5 mg/ml icg via the central venous line. The injection was performed after the first graft was made; lima to lad, the vessel was imaged and then within minutes the subject's blood pressure plummeted. Only one injection was made. The subject's pressure could not be maintained. The attending nurse reported that the subject's lungs also appeared to be damaged, and even after transfer to the pump, it was difficult to sustain the subject's pressure. The subject remained on pump for 57 minutes. At the time of the telephone report at 11:52 am, the subject was off pump and her pressure was 60/42. They were still watching her carefully. By the end of the conversation at 12:07 pm, the subject's systolic pressure had risen to 90 mmhg and she appeared to be improving. Up to the point of the reaction, the surgery was completely normal and progressing routinely. The cardiac surgeon classified the event as total system dilation, possibly related to ic-green administration. The pt had rec'd typical concomitant medication during the surgery, anesthetic -fentanol-, propofol, "cyboflourine" and she was heparinized. Due to the fact this was the first vessel imaged, no protamine was on board. Known allergies included nickel, lisinopril, and "dosacyclanine". Concomitant medications included lipitor, atacand, and prilosec. Additional info was requested. September 21, 2007, via telephone. The attending nurse was contacted for further info related to the event. Upon further review at the hosp, it was reported that the event be changed to anaphylactic shock probably related to ic-green- administration. Further information related to the suspected lung damage was requested. Oxygen saturation had been between 98 - 100%, but once the reaction occurred she had decreased to approx 80%, and remained there for an extended period of time. It was also reported that her blood gases were measured and were at 7. 3 ph. Once she was off pump they had to diverse 5 l. The entire surgical team had assessed the event and ruled out air embolus as the source of the damage to the lungs and the drop in pressure. The graft was already hooked up and was deemed patent. There was no sign of embolus. The heart was beating and contracting perfectly with good sinus rhythm. Some tachycardia was reported. The pt was extubated on the same day, and that she was doing well. Cardiac surgeon classified the event as anaphylactic shock, related to icg. Due to the fact that this event is known in product labeling, although serious and life threating, it is not unexpected and, therefore, does not quality for 7 or 15 day reporting, but 30 day medical device reporting with form fda 3500a. It will be simultaneously submitted to akorn, inc. And the fda. Further info was requested and is awaited. October 8, 2007 via facsimile. The images of the graft was requested, and rec'd on 10/09/07, and has been reviewed. No unusual findings are present. There was slight leakage at the anatomic site, otherwise the graft was patent with vigorous downstream flow. Surgical information surgery start: 0752, time of icg injection 0925, time of adverse reaction 0927, time patient placed on pump 0953, time patient taken off pump 1050, time patient taken out of or 1230, total time in icu: 2 days. The following interventions were performed to resuscitate patient: epinephrine -10 mg- was administered between 0927 - 0953. Fluids. Hydrocortisone - 100 mg-, benadryl -50mg-, mechanical bypass required: 0953 - 1050. Blood products were administered after bypass. No add'l monitoring was performed on the pt during the time of the event, other than standard post bypass monitors. Blood pressure: prior to reaction: 120/64, no sbp available immediately after reaction. With pharmacological intervention: sbp 60 - 70 mmhg up to bypass pump. Oxygen saturation: prior to reaction: 99%, post reaction: once sbp resumed 99%; blood gases: prior to reaction: ph = 7. 39, hgb = 10. 5, pco2 = 32. 5, hct = 32. 5, po2 =325, hco3 = 21. 1, immediately after on bypass pump: ph = 7. 24, hgb = 5. 9, pco2 = 43. 6, hct = 18. 6, po2 = 390, hco3 = 18. 2. Other tests performed: electrolytes: prior to reaction: na = 139, ci = 111, k+ = 3. 5, ca2+ = 0. 89, after reaction: na = 135, cl = 100, k+ = 3. 4, ca2+ = 0. 88 as of approx a month after the original date, patient doing well and recovered from event. Dose or amount: 2. 5 mg; frequency: once; route iv. Dates of use: 2007. Diagnosis or reason for use: imaging coronary arterty bypass grafts during cabg surgery.
Patient Sequence No: 1, Text Type: D, B5