Manufacturer's investigation conclusion: a direct correlation between the device and the patient¿s expiration cannot conclusively be determined through this investigation.No product available for investigation.The relevant section of the device history records for (b)(6), were reviewed and showed no deviations from manufacturing or qa specifications.The implant kit was shipped on (b)(6) 2020.The heartmate 3 lvas ifu is currently available.Section 1 of this document lists bleeding and death as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.The patient care and management section provides information regarding anticoagulation, including the recommended international normalized ratio (inr) values.No further information was provided.The manufacturer is closing this event.
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