Catalog Number 500101 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Hemolysis (1886); Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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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.(b)(4).
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Event Description
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While supported by the tah-t, the patient has experienced the following adverse events as defined by intermacs: 389 days post implant - infection i location pump/related - drive line i type: bacterial.703 days post implant - bleeding.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 july 1, 2021 through march 31, 2022 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.Ra-1788 (b)(6) follow-up report 1.
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Event Description
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During the last reporting period, it was reported that the patient had experienced the following adverse events as defined by intermacs.5 days post implant - hemolysis.5 days post implant - right heart failure.27 days post implant - hemolysis.27 days post implant - right heart failure.121 days post implant - hemolysis.180 days post implant - hemolysis.345 days post implant - hemolysis.786 days post implant - hemolysis.926 days post implant - hemolysis.The patient subsequently received a heart transplant after 1123 days of tah-t support.
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Search Alerts/Recalls
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