Catalog Number 500101 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemolysis (1886); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Renal Failure (2041); Thrombosis/Thrombus (4440); Renal Impairment (4499); 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 thetah-t, the patient has experienced the following adverse events as defined by intermacs: 1 days post implant: bleeding.1 days post implant: renal dysfunction.134 days post implant: other sae.As of september 30, 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 april 1, 2021 through june 30, 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 (b)(4) pt (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 event as defined by intermacs: 135 days post implant - renal dysfunction.As of june 30, 2021, it was reported that the patient was still supported by a tah-t.
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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.7 days post implant - hemolysis.30 days post implant - hemolysis.85 days post implant - hemolysis.202 days post implant - hemolysis.363 days post implant - hemolysis.513 days post implant - hemolysis.608 days post implant - infection.656 days post implant - hypertension.653 days post implant - other sae.653 days post implant - renal dysfunction.The patient subsequently received a heart transplant after 684 days of tah-t support.
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Manufacturer Narrative
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Additional information has been provided in section b5 and h6.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 pt 124167 (di_228) follow-up report 2.
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Search Alerts/Recalls
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