It was reported that due to right ventricle dysfunction, while in or (operating room) post implant, an rvad (rotoflow device) was inserted to provide right ventricle support.Patient also required continuous veno-venous hemofiltration (cvvh) support for kidney function.
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Manufacturer's investigation conclusion: a specific cause for the reported events, as well as a direct correlation to heartmate 3 lvas, serial number: (b)(6), could not conclusively be determined.It was reported that the patient was implanted with an rvad due to right ventricle dysfunction post implant.Additionally, the patient was placed on continuous veno-venous hemofiltration (cvvh) support for kidney function.Multiple attempts to gather additional information was attempted; however, none was provided.The patient remains ongoing on heartmate 3 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 pump was shipped on (b)(6) 2020.The heartmate 3 lvas ifu lists renal dysfunction and right heart failure as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.No further information was provided.The manufacturer is closing the file on this event.
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