Catalog Number 500101 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Respiratory Failure (2484); Thromboembolism (2654); Multiple Organ Failure (3261); Renal Impairment (4499)
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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 july 1, 2019 through september 30, 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.Ce (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: 1 days post implant - bleeding.2 days post implant - renal dysfunction.5 days post implant - respiratory failure.13 days post implant - other sae.17 days post implant - venous thromboembolism.25 days post implant - other sae.88 days post implant - infection i location positive blood cultures, mediastinum i type: bacterial.97 days post implant - bleeding.241 days post implant - infection i location mediastinum i type: bacterial.317 days post implant - bleeding.As of september 30, 2020 it was reported that the patient was still supported by a tah-t.
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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: 359 days post implant - bleeding.370 days post implant - bleeding.370 days post implant - infection | location : positive blood cultures | type: unknown.373 days post implant - respiratory failure.The patient subsequently expired with a cause of death listed as multisystem organ failure (msof) after 374 days of tah-t support.
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Manufacturer Narrative
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Intermacs patient registry data collected from october 1, 2020 through march 31, 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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Search Alerts/Recalls
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