Manufacturer's investigation conclusion: a specific cause for the reported infection and bleeding event as well as a direct correlation to heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(4), could not be conclusively determined through this evaluation.The patient remains ongoing on hm3 lvas, serial number (b)(4), and no further events have been reported at this time.The heartmate 3 lvas ifu, rev.C, and the heartmate 3 patient handbook, rev.D, are currently available.Section 6 of the ifu, ¿patient care and management¿, lists infection as a potential late postimplant complication.Section 6 of the ifu, ¿patient care and management¿ (under "anticoagulation"), outlines the recommended anticoagulation regimen, including inr range for patients using the heartmate 3 lvas, as well as the suggested anticoagulation modifications in the event that there is a risk of bleeding.Several sections of the ifu and patient handbook provide care instructions regarding how to prevent infection as well as suggested responses in the event of infection.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 15apr2021.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.No further information was provided.The manufacturer is closing the file on this event.
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