Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the reported events could not be conclusively determined through this evaluation.The account reported that on (b)(6) 2018, the patient had slurring of words (dysarthria) and confusion.Neurology was consulted and a computed tomography (ct) scan of the head was done, which revealed that no acute process had occurred.On (b)(6) 2018, the patient was found to have dysphagia and needed an entech tube for medications and feedings.A percutaneous endoscopic gastrostomy (peg) tube was placed for feedings on (b)(6) 2018.Left upper extremity swelling was noted on (b)(6) 2020.An ultrasound (us) was done which revealed a deep vein thrombosis (dvt) that was nonocclusive, in left subclavian (sc) vein.The patient was reportedly already on anticoagulation at this time.On 11feb2018, the patient was found to have hypoxia and difficulty breathing.The rapid response team (rrt) was called and the patient was intubated and then transferred back to the intensive care unit (icu).It was determined that the patient had hypoxic, hyper-carbic respiratory failure which was most likely caused from aspiration pneumonitis.A right heart catheterization (rhc) was obtained to evaluate hemodynamics.On (b)(6) 2018, a tracheostomy (trach) was placed on (b)(6) 2018, another ultrasound done which showed an occlusive thrombus in the distal, left subclavian vein.On (b)(6) 2018, radiology was consulted and stated that the left subclavian vein was only partially occluded.Per the patient¿s doctor, no intervention was to be performed.The events reportedly remained ongoing.The patient remained ongoing on heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), until (b)(6) 2018 when the patient ultimately expired.The device was not returned for evaluation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 21apr2017.The heartmate 3 lvas ifu and the heartmate 3 lvas patient handbook are currently available.Section 1 of the ifu lists respiratory failure, other neurological event (not stroke related), and venous thromboembolism as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 of the ifu also lists thromboembolism and neurological dysfunction as potential late postimplant complications.Additionally, section 6, under ¿anticoagulation¿, provides the recommended anticoagulation regimen, including inr range, as well as suggested anticoagulation modifications.No further information was provided.The manufacturer is closing the file on this event.
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