It was reported that a patient who had received a 15 mm masters aortic valve and a 15mm and 17mm masters mitral valve died on (b)(6) 2020 of unknown causes.As there is not enough information to determine relation to the abbott devices, this event is being conservatively reported.On (b)(6) 2017 a 15mm sjm masters series hemodynamic plus valve mitral valve was implanted.On (b)(6) 2017 the patient underwent an implant procedure of a 15 mm aortic valve, 15 ahpj-505.Post implant, in 2018, the patient was treated for a variety of comorbidities including "failure to thrive" requiring a feeding tube, c-diff infection and recurrent bronchiolitis.On (b)(6) 2020, the 15 mm masters valve was exchanged with a 17 mm sjm masters series hemodynamic plus mitral valve.Since the implant of the 17mm valve, the patient developed complete heart block, suffered cardiac arrest, a subdural hematoma, severe renal failure, pancreatitis and bacterial pneumonia.On (b)(6) 2020 the patient was brought in for an unrelated procedure which identified an "obstructed circumflex artery." it was determined the obstruction was secondary to compression of the 17mm mitral valve.The site reported the patient¿s death occurred on (b)(6) 2020.Additional information has been requested to determine cause of death.Us0545-4,crd 945, s554619101,s538340301,s536621601.
|