It was reported that the patient was implanted on (b)(6) 2018 and the patient remained in cardiogenic shock post-implant with the left ventricle still enlarging despite mechanical circulatory support (mcs).The patient remained hypertensive with polymorphic ventricular tachycardia and non-sustained ventricular tachycardia causing pre-syncopal and syncopal symptoms.The patient underwent a computed tomography (ct) scan, echocardiogram, and labs.It was not known whether the patient experienced any alarms.It was corrected by the account that the patient did not receive any outflow graft revisions but instead received an inflow cannula revision on (b)(6) 2018.It was noted that the patient had inflow cannula positional change with left ventricular assist device (lvad) dysfunction.The patient was then taken back to the operating room the same night for exploration due to a large hemothorax.The patient subsequently underwent evacuation of a large number of clots, washout, and closure.The patient was discharged on (b)(6) 2020, and it was noted that the patient had done fairly well.No additional information was provided.
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Section a2, b3, h4, h6 (patient and device codes): correction section b5: additional information.Manufacturer's investigation conclusion: this report was determined to be duplicate to mfr #.The report of inflow cannula positional change could not be confirmed as no images were provided and there is no product available for investigation.A specific cause for the report of inflow cannula positional change, hemothorax, ventricular tachycardia, hypertension, and post-implant cardiogenic shock with enlarging left ventricle could not be conclusively determined through this evaluation.In addition, a direct correlation with heartmate ii lvas, serial number (b)(6), could not be conclusively determined.The patient remained ongoing on (b)(6) following this event with no further related issues until he underwent a pump exchange on (b)(6) 2020.(b)(6) has not yet been returned to this date.There is no product available for investigation.The heartmate ii lvas ifu lists bleeding and cardiac arrhythmia as adverse events that may be associated with the use of heartmate ii left ventricular assist system.Section 5 entitled ¿surgical procedures¿ explains how to insert and orient the sealed inflow conduit and states, ¿the opening of the sealed inflow conduit should be directed toward the mitral valve and away from the interventricular septum.¿ section 6 entitled ¿patient care and management¿ lists arrhythmia as a potential late postimplant complication.Section 6 also provides details regarding the recommended anticoagulation therapy and inr range.Further, section 6 states that post-implantation hypertension may be treated at the discretion of the attending physician.Any therapy that consistently maintains mean arterial blood pressure less than 90 mm hg should be considered adequate.No further information was provided.The manufacturer is closing the file on this event.
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