Manufacturer's investigation conclusion: a direct correlation between heartmate ii left ventricular assist system (lvas), serial number (b)(6), and the reported patient outcome could not conclusively be established through this evaluation.Additionally, a specific cause for the patient's sepsis, and hemorrhagic stroke could not conclusively be determined through this evaluation.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.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.The heartmate ii lvas instructions for use (ifu), rev.C and the heartmate ii patient handbook, rev.C are currently available.Section 1 of this ifu lists stroke, bleeding, sepsis, and death as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.Section 6 outlines the suggested anticoagulation regimen and international normalized ratio (inr) range that should be maintained for patients using the heartmate ii lvas as well as the suggested anticoagulation modifications.Care instructions regarding infection are also provided in the ¿patient care and management¿ section of this ifu.The patient handbook contains care instructions for preventing infection which are outlined in various sections of this document.No further information was provided.The manufacturer is closing the file on this event.
|