Model Number 50CC OR 70CC |
Device Problems
Device Operational Issue (2914); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemolysis (1886); Neurological Deficit/Dysfunction (1982); Viral Infection (2248); Patient Problem/Medical Problem (2688); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440); Insufficient Information (4580)
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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, 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) initial.
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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: twenty (20) days post implant - device malfunction and/or pump thrombosis.Twenty (20) days post implant - neurological dysfunction - seizure.As of (b)(6) 2017 it was reported that the patient was still supported by the tah-t.
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Manufacturer Narrative
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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 inmplanted tah-t.Ce 5519 pt 113095 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 event as defined by intermacs: 741 days post implant - device malfunction and/or pump thrombosis.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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Additional information has been provided in section b5 and h6.Intermacs patient registry data collected from (b)(6) 2021 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.(b)(4) follow-up report 2.
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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: 1258 days post implant - device malfunction and/or pump thrombosis; 1299 days post implant - device malfunction and/or pump thrombosis; 1398 days post implant - infection i location other i type: viral; 1481 days post implant - device malfunction and/or pump thrombosis.As of (b)(6) m2021, it was reported that the patient was still supported by a tah-t.
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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 113095 (di_480) follow-up report 3.
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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.31 days post implant - hemolysis.101 days post implant - hemolysis.128 days post implant - hemolysis.334 days post implant - hemolysis.551 days post implant - hemolysis.726 days post implant - hemolysis.942 days post implant - hemolysis.1116 days post implant - hemolysis.1258 days post implant - hemolysis.1509 days post implant - hemolysis.As of march 31, 2022, it was reported that the patient was still supported by the tah-t.
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Manufacturer Narrative
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The syncardia 50cc or 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 50cc or 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) 2022 regarding adverse events was reviewed.Patients were de-identified therefore a one-ton-one correlation could not be made between the patient and the lot number of the implanted heart.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.Emdr pt 113095 (di_480) follow-up report 4.
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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.1976 days post implant - neurological dysfunction.The patient subsequently expired with a cause of death of listed as nervous system: neurological dysfunction after 1978 days of tah-t support.
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Search Alerts/Recalls
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