Patient (b)(6).
This report is filed as an enlarged atrial septal defect occurred following the mitraclip procedure.
The cascading adverse events include death.
It was reported that on (b)(6) 2020, a mitraclip procedure was performed for mitral regurgitation (mr) grade 4.
Two mitraclips were successfully implanted, reducing the mr to grade 2, without a device issue.
On (b)(6) 2020, after defecatio, the patient had sudden cardiac arrest.
The patient was found unconscious, without spontaneous breathing.
Cardiopulmonary resuscitation (cpr) was performed and the patient was intubated.
Per physician, the cardiac arrest was less likely due to drug interaction.
The cardiac arrest was hypothesized to be due to takotsubo syndrome with consequent ventricular tachycardia/ventricular fibrillation and most likely due to a decrease of preload and drop of arterial pressure after defecation resulted in acute right ventricular failure and right-left shunt via atrial septal defect (asd).
The event resulted in severe neurological complications, an ischemic stroke with left-side hemiparesis, and leaving the patient in a coma.
Medications had been provided as treatment.
On (b)(6) 2020 per imaging, the ischemic stroke was verified within 2 zones of the right hemisphere.
An echocardiogram displayed takotsubo syndrome.
Per imaging, a new akinetic zone was observed, along with slightly elevated cardiac lab, troponin.
There was no coronary occlusion.
The patient remained unconscious and intubated.
That same day, on (b)(6) 2020, severe oxygen desaturation, severe respiratory failure, along with severe arterial hypoxemia (sao2 to 40%) and right ventricular failure occurred.
Reportedly, this was due to a massive right to left shunt via an asd.
There was a reversal of pulmonary hypertension to the base-line level (90-100mmhg) due to hypoxic vasoconstriction.
Severe congestion in the viscera along with pulmonary hypovolemia was observed.
Medications were provided and cpr was performed.
Acute right ventricular failure occurred, which led to death that same day.
The mitraclips remained stable and well seated on the leaflets.
Per physician, the events were unrelated to the implanted mitraclips.
There was no device malfunction reported.
No additional information was provided regarding this issue.
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