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Catalog Number 500101 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Death (1802); High Blood Pressure/ Hypertension (1908); Neurological Deficit/Dysfunction (1982)
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Event Type
Death
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Manufacturer Narrative
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The syncardia 70cc temporary total artificial heart (tah-t) is an implantable pulsatile biventricular replacement device that replaces a patient's native ventricles and valves and pumps blood to both the pulmonary and systemic circulation systems.The syncardia 70cc tah-t is indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.The syncardia tah-t system is intended for use inside and outside the hospital.Investigation summary: intermacs patient registry data collected between april 1, 2014 and september 30, 2017 regarding adverse events was retrospectively reviewed.Patients were de-identified therefore a one-to-one correlation could not be made between the patient and the lot number of the implanted tah-t.These events were assessed and are being reported in response to an update to the mdr complaint sources.With a review of the available information, there is no evidence of a device malfunction or performance issues that would impact the reported events.Possible clinical factors that may have contributed to these events include the patients pre-existing history and related comorbidities (see section b7), the progression of their underlying disease, issues related to the therapeutic use of anticoagulants, antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to these events.This device is used for treatment, not diagnosis.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4).(b)(6).
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Event Description
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While supported by the tah-t, the patient experienced the following adverse events as defined by intermacs: 345 days post implant - device malfunction and/or pump thrombosis, 1241 days post implant - device malfunction and/or pump thrombosis, 1248 days post implant - hypertension v3.0, 1248 days post implant - infection/location: other/type: bacterial, 1262 days post implant - infection/location: urinary tract/type: bacterial, 1308 days post implant - infection/location: positive blood cultures, pulmonary/type: bacterial.The patient subsequently expired with a cause of death listed as nervous system: neurological dysfunction after 1334 days of tah-t support.
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Search Alerts/Recalls
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