Catalog Number 500101 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Unspecified Infection (1930); Respiratory Failure (2484); Thrombosis/Thrombus (4440)
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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 from (b)(6) 2019 through (b)(6) 2020 regarding adverse events was 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.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, 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.(b)(4).
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Event Description
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While supported by thetah-t, the patient has experienced the following adverse events as defined by intermacs: 18 days post implant - infection i location other i type: bacterial.18 days post implant - respiratory failure.150 days post implant - device malfunction and/or pump thrombosis.As of (b)(6) 2020 it was reported that the patient was still supported by a tah-t.
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Manufacturer Narrative
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Intermacs patient registry data collected from (b)(6) 2020 through (b)(6)2021 regarding adverse events was 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.Ce 5660 pt (b)(6) follow-up report 1.
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Event Description
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Since the last reporting period, the patient experienced the following adverse events as defined by intermacs: 122 days post implant - infection.139 days post implant - neurological dysfunction.138 days post implant - respiratory failure.197 days post implant - neurological dysfunction.197 days post implant - respiratory failure.138 days post implant - device malfunction and/or pump thrombosis.The patient subsequently expired with a cause of death listed as wihdrawal of support after 203 days of tah-t support.
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Search Alerts/Recalls
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