Manufacturer's investigation conclusion: a direct correlation between the reported events (infection, bleeding) and heartmate 3 left ventricular assist system (hm3 lvas), serial number (b)(6) could not be conclusively established through this evaluation.A specific cause for the reported events could not be conclusively determined through this evaluation.The center reported that the patient experienced hematoma of the crt-d (cardiac resynchronization therapy defibrillator) site with the suspicion of ogf (outflow graft) infection.The start date was listed as (b)(6) 2020.The crt-d was extracted on (b)(6) 2020 in the operating room, and infection of the crt-d site was confirmed.The event was reported as possibly related to the device.No alarms were reported for this event.The patient ultimately expired on (b)(6) 2020 (manufacturer report number: 2916596-2020-06178).Hm3 lvas, serial number (b)(6) was not explanted for evaluation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on (b)(6) 2016.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.The heartmate 3 lvas instructions for use (ifu) is currently available.Section 1 of this ifu lists infection (local, driveline and pump pocket) and bleeding as adverse events that may be associated with the use of the hm3 lvas.Care instructions in regard to preventing infection are provided in various sections of this ifu, including a section entitled "controlling infection." section 6 provides information regarding anticoagulation, including the recommended international normalized ratio (inr) values.The hm3 lvas patient handbook is also currently available.This handbook also contains information about preventing infection.No further information was provided.The manufacturer is closing the file on this event.
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