Manufacturer's investigation conclusion: a direct relationship between heartmate 3 left ventricular assist system (lvas), serial number (b)(4), and the reported events and patient outcome could not be conclusively determined through this evaluation.The device was not returned for evaluation.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 (hm3) left ventricular assist system (lvas) instructions for use (ifu) (rev.C) is currently available.Renal dysfunction, cardiac arrhythmia, and death are listed as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.Additionally, section 6 ¿patient care and management¿ lists arrhythmia as a potential late postimplant complication that may be associated with the use of heartmate 3 lvas.No further information was provided.The manufacturer is closing the file on this event.
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The patient's post-operative course was complicated by ventricular tachycardia, renal failure, and cardiogenic shock requiring inotropes and vasopressors.The patient developed progressive renal failure despite optimization of hemodynamics with worsening uremia and metabolic acidosis.The patient was not a candidate for dialysis given his overall critical illness and poor outcome.After discussions with the family, the patient was transitioned to comfort care and the patient passed away.
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