It was reported that the patient was taken back to the or (operating room) due to inflow cannula position pointed towards the septum, which was diagnosed by x-ray.The clinician observed the surgeon place sutures around the outflow bend relief and tact to diaphragm, as well as a suture in the bend relief and tack to chest wall.The clinician observed the or team utilizing echo (echocardiogram) for optimization of inflow position.The cannula was observed to be parallel with the septum in the left ventricle.The chest was closed and the patient was transferred to the intensive care unit (icu).The pump components operated as intended.It was reported on (b)(6) 2022 that the patient was improving, extubated, with stable flows.A right ventricular assist device (rvad) was implanted due to post operative rv (right ventricle) failure.The rvad was a maquet pump and circuit without an oxygenator.On (b)(6) 2022 it was reported that the patient's right heart failure improved after support, with echo showing normal values.It was also reported that the patient's rvad was discontinued the previous day due to recovery.
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Manufacturer's investigation conclusion: the report of the inflow cannula being positioned towards the septum could not be confirmed through the submitted x-ray image.Additionally, a direct correlation between the reported right ventricular (rv) failure and the device could not be conclusively established through this evaluation.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6).No further events have been reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu) is currently available.Section 1, "introduction," lists right heart failure as an adverse event that may be associated with the use of heartmate 3 lvas.Section 5 entitled ¿surgical procedures¿ explains how to insert the pump in the ventricle and instructs the user to take care to avoid orienting the inlet towards the interventricular septum.Pump function will be compromised in the presence of inlet obstruction.This section also outlines the steps to reorient the pump.No further information was provided.The manufacturer is closing the file on this event.
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