Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(4), and the reported wound dehiscence cannot be conclusively determined through this evaluation.The patient remains ongoing on heartmate 3 lvas, serial number (b)(4).No product is available for investigation.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 10sep2020.The heartmate 3 lvas instructions for use (ifu), rev.C and the heartmate ii patient handbook, rev.D are currently available.The heartmate 3 lvas ifu lists wound dehiscence as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.No further information was provided.The manufacturer is closing the file on this event.
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It was reported that after lvad implantation, the patient had some issues with thoracotomy wound dehiscence.The cause of the wound dehiscence was determined to be poor wound healing and malnutrition.There were no signs of infection, but the site was cleansed and packed.The patient had no fevers or chills.The patient¿s white blood count was within normal limits and no cultures or imaging was performed.It was reported that the thoracotomy wound dehiscence was related to the lvad procedure.The patient is alive and stable and has had no further issues with the thoracotomy site.
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