It was reported that the patient was admitted due to acute right ventricular (rv) failure on (b)(6) 2024, which existed prior to left ventricular assist device (lvad) implantation.The patient was given vasopressin and norepinephrine that was complicated by acute renal failure, which required continuous renal replacement therapy (crrt).While still inpatient, the patient was noted to be critically sick lacking meaningful alertness or interactions on (b)(6) 2024.Once stabilized, the patient never regained meaningful interaction or alertness.Rv failure and renal failure resulted in patient decline due to multiorgan system failure.The patient was made do-not-resuscitate and dialysis was stopped on (b)(6) 2024.The patient was placed on comfort care and the decision was made on (b)(6) 2024 by the patient's family to withdraw lvad support.The patient passed away on (b)(6) 2024 after the lvad was turned off.No autopsy was performed and the lvad was not explanted.The clinician deemed the patient's death to not be lvad related, as the device was functioning as intended at the patient's time of death.
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Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the patient¿s outcome could not be conclusively determined through this evaluation.The outcome was not considered to be device or therapy related, and the (b)(6) was operating as intended.An autopsy was not performed, and the device was not explanted for evaluation.The heartmate 3 lvas ifu (instructions for use) outlines potential adverse events, including multiple types of organ failure/dysfunction and death, that may be associated with the use of heartmate 3 lvas.Care instructions in regard to preventing infection are provided in various sections of the ifu.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviation from manufacturing or quality assurance specifications.The heartmate 3 lvas ifu is currently available.Section 1 of the ifu, ¿introduction,¿ lists potential adverse events, including multiple types of organ failure/dysfunction and death, that may be associated with the use of the heartmate 3 left ventricular assist system.No further information was provided.The manufacturer is closing the file on this event.
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