This case involves a 50-year-old female patient with no significant past medical history aside from a mitral valve heart defect that needed to be repaired surgically. The surgeon opted to use a new annuloplasty Myxo Ring, Edwards Lifesciences Model 5100 before it was FDA approved. During the procedure, the surgeon sutured and obstructed the patient’s circumflex artery. As a result, the patient experienced several rounds of V-fib and had to be cardioverted 4 times. An immediate post op EKG showed ST elevations in leads II, III and aVF with depressions in the reciprocal leads. The obstruction was never diagnosed and the acute cardiac event resulted in severe LV damage. The surgeon did not recognize, diagnose or treat the AMI, and instead sent her home with a diagnosis that she had cardiac stunning from a potassium deficiency. The patient’s long-standing cardiologist finally revealed the heart damage and the patient was given an ICD and is now on a breadth of cardiac medications.
Question(s) For Expert Witness
1. Did this surgeon operate within the standard of care by offering a patient a device that was not yet FDA approved?
2. Is this a common occurrence to nick the circumflex artery and if so did the surgeon manage the mistake properly?
Expert Witness Response E-003939
There are a few issues in this case. The first is the device; I'm sure the patient consented to using one that was not yet FDA approved. Second, the doctor nicking the coronary artery is not malpractice, as this is a widely recognized complication of this procedure. If the doctor did not notice that the back of the heart wasn't contracting properly, he would've had to do a vein graft. In order to determine from this point forward where there could be sub-standard care, several questions need to be investigated further. How long did the mitral valve repair take? What was the status of the heart when it was recovered? Did he make an attempt to fix it, or did he overlook the problem?
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