Manufacturer's investigation conclusion: the reported inflow cannula misalignment could not be confirmed through this evaluation as no computed tomography (ct) scan images depicting the misalignment were submitted for review.The patient remains ongoing on heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(4), and no further related events have been reported at this time.The hm3 lvas instructions for use (ifu) 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 as pump function will be compromised in the presence of inlet obstruction.The steps to adjust the orientation of the pump are also outlined.The heartmate 3 lvas ifu, rev.C and the heartmate 3 patient handbook, rev.D, are currently available.The ifu, "surgical procedures" (under ¿preparing the ventricular apex site¿), provides instructions on how to insert the pump in the ventricle and instructs the user to take care to avoid orienting the inlet towards the interventricular septum as pump function will be compromised in the presence of inlet obstruction.The steps to adjust the orientation of the pump are also outlined in this section.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 02jun2021.No further information was provided.The manufacturer is closing the file on this event.
|