Section b5: chronic driveline infection captured under mfr.Report # 2916596-2022-00288 and 2916596-2021-06662.Manufacturer's investigation conclusion: a specific cause for the reported driveline infection and hypertension as well as a direct correlation to heartmate (hm) 3 left ventricular assist system (lvas), serial number mlp-025646, 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 1 of the ifu, ¿introduction¿, lists infection (local, driveline, and pump pocket) and hypertension as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.Section 6 of the ifu, ¿patient care and management¿, lists infection as a potential late postimplant complication.This section also states that adequate therapy for post-implantation hypertension should consistently maintain the mean arterial blood pressure below 90 mm hg.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 mlp-025646 were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 05apr2021.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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