It was reported that on (b)(6) 2019, a male patient with a history of clot, myocardial infarction, stent placement in lad, and right ventricular dysfunction, planned to undergo a convergent and left atrial appendage (laa) management procedure.Given the patients¿ history of clot, the surgeon decided first to manage the laa.Ports were placed in the normal fashion and pericardium was opened without incident.The laa was clipped with an atriclip pro v50 and within 5 minutes of placement, patient experienced sudden hypotension.The surgeon looked at the echo and noted it was right ventricular dysfunction.Compressions were started on the table and the pressure became stable.The surgeon made the decision to remove the clip, with the two forceps he pulled the clip apart and removed the clip without incident.Patient again became hypotensive; compressions were started, and pressure resumed after about 10 minutes.Patient became hemodynamically stable with short runs of ventricular tachycardia and had to be cardioverted 4 separate times and shocked once.The convergent part of the procedure was not completed.Then the port sites were closed, and the patient was brought to the cath lab for the coronary study.The coronary study showed no immediate causes for the hypotensive episodes.Post- procedure, the following day patient was due to be extubated, but the patient expired.The surgeon stated patients¿ events were associated with his pre-existing condition.This was a procedural complication, there was not reported device malfunction.
|