Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system, serial number (b)(6) and the reported events cannot be conclusively determined through this evaluation.The patient remains ongoing on the heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6).No product is available for investigation.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) and the heartmate 3 patient handbook are currently available.Section 1 of the ifu, ¿introduction¿, lists wound dehiscence, arterial non-central nervous system (cns) thromboembolism, and infection as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6, ¿patient care and management¿, also lists thromboembolism as a potential late postimplant complication.Additionally, section 6, under ¿anticoagulation¿, provides the recommended anticoagulation regimen, including international normalized ratio (inr) range, as well as suggested anticoagulation modifications.Section 6 of the ifu, ¿patient care and management¿, also lists infection as a potential late postimplant complication.Furthermore, several sections of the hm3 ifu and patient handbook provide care instructions regarding how to prevent infection as well as suggested responses in the event of infection.No further information was provided.The manufacturer is closing the file on this event.
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