It was reported that the patient was experiencing poor right ventricle (rv) function.The patient was failing to thrive following vad implant.The site claimed that the primary issue appeared to be rv dysfunction causing an acute kidney injury, also with significant hypoxemia.The patient is poorly responsive to diuretic.Will add ino via nc today.The site continued milrinone, hold diuresis.Allow mean arterial pressure to run 85.Continue foley catheter.Inotropes were started on (b)(6) 2018 and discontinued on (b)(6) 2018.Ino was started on (b)(6) 2018 and weaned off on (b)(6) 2018.
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Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the reported events could not be conclusively determined through this evaluation.The account communicated that on (b)(6) 2018, the patient developed atrial fibrillation (afib) with rapid ventricular response (rvr), the cause of which was reported as poor right ventricular function.The right ventricular dysfunction also caused hypoxia and acute kidney injury with creatinine levels rising above 2.0.The patient was treated with inotropes, nitric oxide, amiodarone, and lasix.According to the account, the event resolved on (b)(6) 2018 and the patient was stable and discharged on (b)(6) 2020.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No product available for investigation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on 21may2018 under order (b)(4).The current heartmate 3 lvas ifu lists right heart failure and renal dysfunction as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system in section 1, ¿introduction¿.Section 6 entitled ¿patient care and management¿ cautions the user that right heart failure can occur following implantation of the pump and outlines the associated treatment options, including rvad placement.No further information was provided.The manufacturer is closing the file on this event.
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